Join Our Team

Pulse Biosciences is always looking to add the best and brightest minds to our world-class company. Our team is best suited for individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude. If this sounds like a fit for you, we encourage you to explore our current career opportunities below:

To apply for a position, send your resume to careers@pulsebiosciences.com.
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will not be accepted.


Accounting/Finance

Senior Accounting Manager

Posted: October 8, 2019

Current Location: Hayward, CA

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POSITION SUMMARY

Under the direction of the Controller, the Accounting Manager will oversee accounting functions including GL, journal entries, and other designated tasks. This position is responsible for meeting deadlines and will direct a variety of accounting activities including but not limited to monthly close process, reconciliations and audit preparations.

MAJOR DUTIES AND RESPONSIBILITIES

  • Maintain the general ledger of the company
  • Manage the monthly close process, including preparation/review of journal entries, allocations and account reconciliations
  • Manage accruals, including clinical trial and other R&D accruals
  • Act as the Stock Administrator and record all stock-based compensation expense for stock options, restricted stocks and warrants
  • Assist with the preparation and completion of forms 8-K, 10-Qs, and 10-K
  • Prepare and review audit support schedules
  • Produce monthly financial reporting for the executive team on a timely basis
  • Make and implement recommendations to improve accounting policies and procedures
  • Ensure SOX compliance by monitoring accounting policies, procedures and internal controls
  • Provide technical accounting expertise and knowledge
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration and teamwork
  • Performs other related duties as assigned

EDUCATION /EXPERIENCE REQUIREMENTS

Bachelor’s degree in finance/accounting or equivalent experience

QUALIFICATIONS:

  • Big 4 CPA experience
  • 5+ years accounting and reporting experience in public companies
  • Strong understanding of US GAAP and experience with SEC Regulations
  • Previous experience with mid-sized ERP systems, i.e. NetSuite
  • Computer literacy required, with the ability to navigate computer systems with little or no assistance. Proficiency in MS Office specifically with Outlook, Word, Excel (moderate/advanced) and PowerPoint
  • Must possess the ability to multi-task and work in time sensitive situations to meet deadlines
  • High level of attention to detail
  • Must possess excellent interpersonal communication (oral and written), organizational and project planning skills. Must have ability to effectively work and communicate with all levels of employees throughout the company. Should be customer service driven and have positive outlook.
  • Ability to self-motivate and function independently, driven towards superior effort and performance, and the desire to work in a very dynamic environment
  • Collaborative and team-oriented.
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Corporate Controller

Posted: October 8, 2019

Current Location: Hayward, CA

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PURPOSE OF JOB:        

Provide leadership for all financial operations of the Company.  Ensure that the Company has excellent systems and procedures in support of accurate and timely financial reporting requirements.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Hire, train and supervise financial operations staff.  Manage AP/AR, Payroll, GL, Cash, and financial reporting functions.
  • Develop and maintain financial accounting systems that support the Company’s goals and reporting requirements.
  • Develop detailed financial, cost, budget and accounting reports for management review. Analyze and interpret operating results from a financial perspective. Develop financial reports needed to implement business plans and allocate funds.
  • Manage the month end close process including review of GL entries, monthly account reconciliations and analysis of budget-to-actual fluctuations to ensure accuracy of financial results.
  • Manage fixed asset process, including asset acquisition and disposal, and related depreciation and amortization schedules. 
  • Manage stock option administration. Focal point for audit preparation and support of auditors.
  • Develop and maintain policies to ensure accurate accounting, financial reporting and reliable internal controls; ensure financial integrity through strong controls.
  • Create, revise and/or reengineer accounting procedures to streamline reporting activities and to improve and validate accurate reporting.
  • Advise senior management regarding financial objectives and fiscal policies of the Company.
  • All work completed shall be in compliance with the FDA and international CE device regulations and company quality assurance procedures.

EDUCATION REQUIREMENTS:  Bachelors degree in business or equivalent experience required.  CPA and/or MBA preferred.

EXPERIENCE REQUIREMENTS:  Minimum of 10 years of related experience (preferably in the medical device industry) is required.  Must additionally have at least three years of management experience.

OTHER QUALIFICATIONS:  Working knowledge of Generally Accepted Accounting Principles is required. NetSuite, extensive Excel, and MS Access skills strongly preferred.

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Biology

Associate Research Scientist

Posted: October 1, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Under the direction of the Sr. Director I/O Research, conduct in vitro and in vivo pre-clinical research to optimize the stimulation of the immune system using the Nano-Pulse Stimulation Platform. Conduct additional pre-clinical research where the data indicates further research.

Essential Duties and Responsibilities

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as management may deem necessary from time to time.

  • Conducting in vitro biological techniques, including cell culture and bioassays (i.e. ELISA, Flow Cytometry);
  • In vivo skills such as handling and treating rodents, tissue sampling, ex vivo post processing of tissues;
  • Conducting survival surgeries on rodents for internal tumor treatments;
  • Design experiments using syngeneic mouse tumor models to optimize the stimulation of the immune system;
  • Review and provide assessments/analysis of scientific studies;
  • Lead role for studies, training, and other projects as needed;
  • Interacting with other functions with interdepartmental projects, project planning, etc.;
  • Give presentations as required;
  • Working closely in teams executing protocols.

Qualifications and Education

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • BS w/ 10 years, MS w/ 5 years or PhD w/ 3 years of experience in biological science required;
  • Five years of relevant experience in medical device, biotech, biomedical, life sciences field; industry experience is highly desirable;
  • Extensive experience generating and treating tumors in vivo in rodents, including survival surgical experience;
  • Experience with sterile technique, cell culture, standard cellular/molecular biological techniques;
  • Understanding, planning, coordinating and conducting complex research studies;
  • Strong analytical skills and attention to detail;
  • Excellent verbal and writing skills; experience with MS Outlook, Word, and Excel;
  • Strong interpersonal skills; ability to collaborate and work well in a team environment.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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Research Technician

Posted: September 24, 2019

Current Location: Hayward, CA

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Position Summary:

Under the direction of Associate Research Scientist, conduct in vitro and in vivo pre-clinical research to optimize the stimulation of the immune system using the Nano-Pulse Stimulation Platform. Conduct additional pre-clinical research where the data indicates further research.

Essential Duties and Responsibilities:

  • In vivo skills such as handling and treating rodents, tumor cell and formulation injections, tissue sampling, mouse husbandry, ex vivo post processing of tissues
  • Laboratory organization and supply inventory management
  • Working closely in teams executing protocols
  • Perform tissue culture and manage cell culture stocks

Secondary Duties and Responsibilities:

  • Conduct in vitro biological techniques, including cell culture and bioassays (i.e. ELISA, Flow Cytometry)
  • Histology of mouse tissue and image processing
  • Lab cleaning and upkeep

Qualifications and Education:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  • BS/MS in Biology or related scientific field required;
  • 3+ years of relevant experience in medical device, biotech, biomedical, life sciences field, academic laboratory; industry experience is highly desirable;
  • Hands on in vivo experience with mice for dosing, surgeries and tissue harvest
  • Experience with sterile technique, cell culture, standard cellular/molecular biological techniques;
  • Strong analytical skills and attention to detail;
  • Excellent verbal and writing skills; experience with MS Outlook, Word, and Excel;
  • Strong interpersonal skills; ability to collaborate and work well in a team environment.

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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Engineering

Sr. Mechanical R&D Engineer (Systems)

Posted: September 24, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Senior Mechanical R&D Engineer (Systems) will be responsible for developing disposable and non-disposable medical devices for the delivery of high-voltage nanosecond pulsed electric fields. Responsibilities include: taking concepts from early prototypes to volume production, working closely with surgeons to obtain design feedback in a surgical environment, and developing close ties with new vendors. You will play a critical role in an early-stage startup environment with a small R&D team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Design and develop high-volume medical devices that can be manufactured via injection molding, stamping, etching, laser cutting/welding, ultrasonic welding, bonding, etc.
  • Ensure a smooth transition of new products into manufacturing.
  • Manage projects with cross-functional teams following design control processes while generating: requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc. 
  • Exhibit a great attitude as a team player who excels in a demanding start-up environment. 
  • Understand the company’s quality policy and quality system requirements applicable to tasks.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  • Extensive mechanical design expertise with laparoscopic or percutaneous disposable and reusable medical devices.
  • Experience with Catheter design and development a plus.
  • Comprehensive knowledge of 3-D CAD, including drafting standards and GD&T.
  • Intermediate experience with MS Excel, Word, and Project.
  • Proven track record of generating innovative minimally-invasive concepts that can be turned into manufacturable products.
  • Demonstrated experience in managing internal and external development resources to achieve product development goals.
  • Fundamental understanding of mechanical engineering theory including: mechanisms, strength of materials, materials, adhesives, and high-volume manufacturing techniques. Understanding of electronics and circuits a plus.
  • Previous experience in ensuring a smooth transition to manufacturing.
  • Strong work ethics with a team-oriented mindset.

EDUCATION and/or EXPERIENCE

  • BS or MS in mechanical engineering required.  Five years of relevant experience in medical device industry required.  Startup experience a plus.

 

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Principal Mechanical R&D Engineer (Disposable Device)

Posted: July 23, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Principal Mechanical R&D Engineer will be responsible for leading the developent of disposable and non-disposable medical devices for the delivery of high-voltage nanosecond pulsed electric fields.  Responsibilities include: coming up with new concepts then taking the concepts from early prototypes to volume production, working closely with surgeons to obtain design feedback in a surgical environment, and developing close ties with new vendors.  You will play a critical role in an early-stage startup environment with a small R&D team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Leading the design and development of high-volume medical devices which can be manufactured via, stamping, etching, laser cutting/welding, ultrasonic welding, bonding, etc.(desired)
  • Ensure a smooth transition of new products into manufacturing.
  • Manage projects with cross-functional teams following FDA design control processes while generating: requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc. 
  • Exhibit a healthy attitude as a team player or leader who excels in a fast-paced start-up environment. 
  • Understand the company’s quality policies and quality system requirements as applicable to tasks.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or abilities required. 

  • Extensive mechanical design expertise with laparoscopic or percutaneous disposable and reusable medical devices.
  • Demonstrated experience in managing internal and external development resources and design projects through the complete development cycle from concept through full commercial launch of new medical products following the FDA required design control processes.
  • Strong documentation and project skills required.
  • Experience with Catheter design and development a plus.
  • Comprehensive knowledge of 3-D CAD Solidworks, including drafting standards and GD&T.
  • Intermediate level experience utilizing MS Excel, Word, and Project.
  • Proven track record of generating innovative minimally-invasive concepts that can be turned into manufacturable products. 
  • Fundamental understanding of mechanical engineering theory including: mechanisms, injection molding (required), strength of materials, materials, adhesives, and high-volume manufacturing techniques.  Understanding of electronics and circuits a plus.
  • Previous experience in ensuring a smooth transition to manufacturing.
  • Strong work ethics with a team-oriented mindset.

EDUCATION and/or EXPERIENCE:

  • BS/MS in mechanical engineering required.  Ten years of relevant experience with the medical device industry required.  Startup experience desired.

 

 

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Sr. Mechanical R&D Engineer (Disposable Device)

Posted: January 16, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Senior Mechanical R&D Engineer will be responsible for developing disposable and non-disposable medical devices for the delivery of high-voltage nanosecond pulsed electric fields. Responsibilities include: taking concepts from early prototypes to volume production, working closely with surgeons to obtain design feedback in a surgical environment, and developing close ties with new vendors. You will play a critical role in an early-stage startup environment with a small R&D team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Design and develop high-volume medical devices that can be manufactured via injection molding, stamping, etching, laser cutting/welding, ultrasonic welding, bonding, etc.
  • Ensure a smooth transition of new products into manufacturing.
  • Manage projects with cross-functional teams following design control processes while generating: requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc. 
  • Exhibit a great attitude as a team player who excels in a demanding start-up environment. 
  • Understand the company’s quality policy and quality system requirements applicable to tasks.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  • Extensive mechanical design expertise with laparoscopic or percutaneous disposable and reusable medical devices.
  • Experience with Catheter design and development a plus.
  • Comprehensive knowledge of 3-D CAD, including drafting standards and GD&T.
  • Intermediate experience with MS Excel, Word, and Project.
  • Proven track record of generating innovative minimally-invasive concepts that can be turned into manufacturable products.
  • Demonstrated experience in managing internal and external development resources to achieve product development goals.
  • Fundamental understanding of mechanical engineering theory including: mechanisms, strength of materials, materials, adhesives, and high-volume manufacturing techniques. Understanding of electronics and circuits a plus.
  • Previous experience in ensuring a smooth transition to manufacturing.
  • Strong work ethics with a team-oriented mindset.

EDUCATION and/or EXPERIENCE

  • BS or MS in mechanical engineering required.  Five years of relevant experience in medical device industry required.  Startup experience a plus.

COMPANY OVERVIEW:

Pulse Biosciences, Inc. is an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its Nano Pulse Stimulation (NPS) platform. Preclinical studies using NPS on solid tumors in murine models has demonstrated that NPS enables effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death.

Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

 

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Human Resources

Corporate Legal Counsel

Posted: September 24, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

The Commercial/Contracts and Healthcare Compliance Counsel will work closely with sales, marketing, regulatory affairs and across multiple other internal functional groups and cross-functional teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Draft, review, and negotiate various agreements, including domestic and international distribution agreements, specialized product purchase/use agreements with physicians, manufacturing/supply contracts with suppliers of materials or services, professional services agreements, consulting agreements, branding/marketing/PR agreements, joint venture agreements, consents/permissions forms, confidentiality agreements, and other miscellaneous contracts and corporate documents.
  • Work collaboratively with company management and various business units to support commercial and corporate activities.
  • Guide interdisciplinary teams on health care compliance and provide legal advice on daily activities
  • Provide risk management, mitigation counseling
  • Help develop corporate business and compliance policies and practices, participate in field team training and review of promotional materials
  • Advise on applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, patients, advocacy groups and other business partners, including, but not limited to compliance with Federal and state anti-kickback statutes, False Claims Act, the Food, Drug and Cosmetic Act, HIPAA and product liability law
  • Manage contract database.

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

EDUCATION and/or EXPERIENCE

  • J.D. degree from a national law school and strong academic credentials
  • 7+ years of hands-on legal experience supporting corporate and commercial contracting activities and healthcare compliance activities
  • Leading law firm and/or in-house medical device/biotechnology/pharmaceutical industry experience is required
  • Active member of the California State Bar or California State Bar eligibility
  • Strong knowledge of contract documents and concepts and strong drafting skills, attention to details is important
  • Understanding of, and experience with, regulatory framework applicable to interactions with healthcare professionals, patient privacy and related issues
  • Strong understanding of medical device, biotech or pharmaceutical operations and the ability to create policies and programs that work for the business
  • Great negotiating skill, ability to prioritize, handle multiple tasks and work independently under tight deadlines
  • Proven track record of delivering independently and consistently on complex projects under challenging circumstances
  • Ability to communicate effectively both verbally and in writing in both individual and group settings

 

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IT

Salesforce Administrator/Analyst

Posted: September 23, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

Pulse Biosciences is seeking an experienced Salesforce Analyst/Administrator to join the IT team out of our Hayward office. You are right for this role if you consider yourself a self-starter; someone who is able to manage multiple tasks and projects simultaneously, own deliverables end-to-end, and can thrive in a growing environment. The Salesforce Administrator/Analyst is responsible for solution engineering, recommending process improvements, evaluating Third-Party tools and implementing enhancements to the Salesforce system. Additionally, the role will also partner with the Integration Team for automating interfaces between Salesforce and other key enterprise business systems (example: NetSuite Arena, Engineering Applications, Concur, Datawarehouse). This role is expected to contribute in building, optimizing and automating the company's CRM applications landscape over the next few years by implementing and supporting scalable business application tools and processes to support company's growth and initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Collaborate with Sales, Customer Service, SalesOps and Engineering teams to assess business requirements, and formulate project plans to address these needs using Salesforce and compatible tools.
  • Design, develop, test and deploy Salesforce modules and enhancements to build configurable extensions to meet business needs.
  • Own various layers of an enterprise-level CRM applications from the systems perspective; everything from security, data integrity, business rules and logic, UI, and reporting.
  • Work with cross-application technical teams to successfully partner, integrate, troubleshoot Salesforce platform with other connected Enterprise applications.
  • Identify, manage, prioritize, address production issues or enhancement requests using JIRA or equivalent ticketing platform, while adhering to Corporate SDLC and Change Management processes, where applicable.
  • Support the Sales department with quarter-end priorities.
  • Strong analytical, problem-solving and communication skills.
  • Attitude & work ethic adaptable to change in a fast-paced work environment.
  • Evaluate new Salesforce releases and developing/planning for future implementations.
  • Develop, evaluate and support third-party extensions to Salesforce.
  • Support, analyze, optimize customizations including reporting and dashboards, workflows, custom fields, page layouts, Apex classes, triggers, etc leveraging best practices and native functionality within Salesforce.
  • Stay current with Salesforce administration and development best practices.
  • Ability to communicate effectively with non-technical individuals.

QUALIFICATIONS:

  • Salesforce Certified Administrator
  • Expertise on Sales Cloud is a must. Expertise on Service Cloud is a huge plus.
  • Experience on implementing or managing third-party tools and extensions on Salesforce (example Conga Composer, AWS, DocuSign, Marketo, Tableau, etc)
  • Ability to learn and cross train in other business systems
  • Familiarity with designing or debugging APEX/Visualforce solutions in Salesforce.com
  • Experience with Salesforce.com Lightning UX
  • Familiarity with SnapLogic platform is desired, but not required
  • Well versed in SFDC object structures
  • Project Management Experience is a plus
  • Passionate about Data Integrity, Data Modelling and Data Governance
  • Good understanding of web services, their use and troubleshooting
  • Salesforce Community Enthusiast and Contributor is a big advantage

EDUCATION:

  • Bachelor's degree in Engineering or Science
  • 5 - 6 years hands-on verifiable experience as a Salesforce.com Business Systems Analyst and/or Administrator platform, with atleast two full-scale implementations
  • Overall combined development CRM experience of 6-8 years

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

 

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Operations

Buyer/Planner

Posted: September 24, 2019

Current Location: Hayward, CA

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POSITION SUMMARY:

The Buyer / Planner will be responsible for executing the build plan with purchasing to support Production & Engineering.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Manage purchasing for parts and services to support Production, Engineering, Biology, Sales & Marketing.
  • Monitor build plan and inventory levels internally and at our contract manufacturer site to support production.
  • Create and manage work orders to support the build plan.
  • Prepare and present inventory, and supply reports to management.
  • Track and manage supplier delivery schedules and resolves supply issues.
  • Prioritize supply requirements, adjust for ECOs, and schedule changes.
  • Assist in identifying and resolving inventory discrepancies.
  • Manage inventory levels to set and maintain safety stocks and lead times.
  • Identify alternate sources for components with better cost/quality/delivery.
  • Request quotes; negotiate purchase terms, delivery schedules, and performance measurement with suppliers.
  • Prepare and enter PO in NetSuite ERP System for confirmed orders.
  • Obtain internal approvals; document and communicate PO changes to suppliers.
  • Follow-up, track, and expedite goods/services purchases to meet production schedules.
  • Provide input and assists in the implementation of efficiency improvements in all purchasing functions. 
  • Reviews and assists in revising procedures related to purchasing activities to improve accuracy and efficiency.
  • Work with Finance on resolving/reconciling AP/Receiving issues.

EDUCATION and/or EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  • Bachelor’s Degree or equivalent experience preferred
  • 5+ years of related industry experience in a medical device manufacturing environment.
  • Experience working within a rigorous, quality control environment such as FDA cGMP/QSR or ISO. 
  • A strong team player with the demonstrated abilities and willingness to wear “multiple hats”, to perform a wide range of tasks (from menial to analytical) within a dynamic environment, and to support overall goals established for the area. 
  • Experienced with software-based inventory management systems- specific experience with NetSuite ERP software a plus. 

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

 

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Quality/Regulatory Affairs

Regulatory Affairs Manager

Posted: September 24, 2019

Current Location: Hayward, CA

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Position Summary:

This position will be responsible for regulatory activities related to the development and implementation of  regulatory strategies to support the submission and filing of multiple indications (clinical applications or “apps”) in Dermatology and Oncology medical device products in targeted markets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with FDA and corporate partners with regulatory deliverables. In addition, this position will require direct and hands on experience to support the development and implementation of FDA QSR and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.Under the direction of Associate Research Scientist, conduct in vitro and in vivo pre-clinical research to optimize the stimulation of the immune system using the Nano-Pulse Stimulation Platform. Conduct additional pre-clinical research where the data indicates further research.

Description:

  • Develop and implement competitive and effective  FDA regulatory strategies for various Dermatology, General/Plastics and Oncology products including clinical/NSR and identify potential risks associated with proposed strategies
  • Manage and participate in the creation, review, editing, assembly and submission of regulatory documentation such as 510ks, Pre-subs, SIRs, Letter-to-Files, IDEs, and PMAs,) including regulatory responses and agency interactions oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
  • Interacts with regulatory agencies to expedite submissions and/or approval of pending regulatory reviews
  • Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
  • Assist Clinical operations and ensuring clinical study results and reports are suitable for regulatory submissions
  • Serves as regulatory liaison throughout product development lifecycle
  • Participates in some of the followings: product plan development and implementation, regulatory strategy, product labeling, promotional review, risk  assessment, adverse events (eMDR), field action, etc.
  • Ensure alignment of regulatory strategy to business strategy across all functional area including timely approval of new medical devices and continued expansion approvals of marketed products.
  • Serves as regulatory representative to marketing, clinical, research teams and regulatory agencies.
  • Accountable for ensuring that regulatory submissions, technical documentation meet appropriate standards, guidance, and content requirements.
  • Advises development and/or marketing teams on product changes, line extensions, technical labeling, appropriate regulations and interpretations
  • Write regulatory justifications to support design changes and submission filing decisions
  • Carry out responsibilities in accordance with the organization’s policies and applicable laws
  • Support the Pulse Biosciences Quality Policy and Quality System.

Qualifications/Requirements:

  • Adaptable team player with the ability to work cross-functionality.
  • Bachelor degree in a life sciences, engineering, or related discipline.
  • 5 to 10 years of experience in Regulatory Affairs in the medical device including an in-depth knowledge and understanding of the FDA regulatory environment. Dermatology (aesthetics) and General/Plastics Surgery, regulatory experience preferred.
  • Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have hands-on experience preparing, managing and submitting major regulatory submissions.
  • Ability to successfully manage multiple projects and navigate challenges to deadlines.
  • Good communication skills in both verbal and non-verbal.
  • Have solid understanding and proving practices within both FDA QSR regulations and ISO 13485: 2016 quality system management
  • Experienced with both high risk device and non-significant risk device classes (Class III/IIb/IIa/II)

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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