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 email@example.com.
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will not be accepted.
Senior Manager - Technical Accounting, Compliance, and SEC Reporting
Posted: May 15, 2020
Current Location: Hayward, CA
read more >
Reporting to the Corporate Controller, the incumbent in this position will be responsible for all aspects of SEC reporting, technical accounting research related to new and proposed accounting standards and complex accounting transactions, SOX compliance efforts, coordination and review of quarterly tax provisions, and preparation for, and interaction with, internal and external auditors, as well as tax consultants. This position also contributes significantly to the quarterly close process, federal and state tax returns and special projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform technical accounting research as needed and prepare memos documenting conclusions and proper accounting treatment. Interact with external auditors with respect to accounting conclusions reached.
- Maintain external reporting calendar, including scheduling and coordination of independent auditors, internal auditors for SOX compliance, and tax advisors.
- Assist in the preparation of audit schedules for quarterly reviews and annual audit.
- Prepare quarterly Audit Committee materials.
- Manage the Company’s SOX compliance efforts including maintaining the internal control documentation, implementing new controls as necessary and managing the Company’s external SOX consultants including the coordination of testing and review of the related work papers.
- Lead the Company in its transition from SOX 404a to 404b compliance.
- Active role in updating/implementing accounting policies and procedures to respond to changes within the Company and industry, SEC/GAAP regulations and SOX 404 requirements.
- Manage the external reporting function to ensure the accurate and timely filing of the Company’s SEC and other regulatory reporting requirements, including preparing the documents, managing the internal and external review of the documents and filing of the documents. Includes but not limited to Forms 10-K, 10-Q, 8-K and Section 16 Reporting, as well as the proxy statement.
- Manage preparation of the Company's stock-based compensation expense and EPS calculations.
- Prepare and manage tax provision requirements with external tax partner.
- Assist in coordination and review of federal and state tax returns.
- Other special projects as required.
- Other duties as assigned.
EDUCATION and EXPERIENCE:
- BA/BS in business, accounting, or related field.
- CPA license required.
- 10+ years’ of increasingly responsible accounting and reporting experience.
- 3+ years’ SEC reporting experience within a public company.
- 3+ years’ SOX 404 compliance experience, implementation experience a plus.
- Highly proficient in Excel, Word and PowerPoint.
- High level of organization, attention to detail, aptitude for planning/managing deadlines.
- Maintain confidentiality over all finance and accounting matters and information.
- Exceptional communication skills, including the ability to effectively present information to various levels of an organization, including the Audit Committee of the Board of Directors.
- Excellent interpersonal and project management skills with ability to work effectively with multiple functional areas.
- Strong commitment to a team approach, and awareness of team and individual success dependencies.
- Ability to successfully manage multiple projects with competing priorities and tight deadlines.
- Ability in exercising sound judgment and working independently with minimal supervision and/or guidance.
- Proactive problem solver presents problems and recommendations simultaneously.
- Self-motivated, highly driven, independent, and results-oriented.
- Experience with major ERP systems and associated planning and reporting tools.
- Minimum three years’ in a manufacturing environment, preferably medical device.
Clinical Trials Associate
Posted: June 1, 2020
Company Location: Hayward, CA
read more >
The Clinical Trial Associate will support the conduct of clinical trials, track study progress in CTMS and oversee the trial master file (TMF) quality review for the clinical team.
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.
- Support Clinical Affairs Management and CRAs in all activities during pre-study start-up, site initiation, site management, and study close-out;
- Works closely with clinical team and approved vendors in compliance with company internal procedures;
- Assist in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples, if applicable;
- Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study;
- Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements;
- Assist in the development, review, and formatting of study-specific documents, including plans, CRFs, patient documents, reference documents, and study tools;
- Ensure timely completion of study tasks, update trial trackers and study metrics on an on-going basis;
- Acts as Functional TMF Document Specialist for Clinical Affairs, to include submission of documents to and maintenance of the TMF; reviews TMF documents as part of the Quality Review Process;
- Co-monitoring as needed to assist in review the investigative site file (ISF), perform device accountability and other tasks as deemed necessary;
- Liaises with project team members regarding study site issues;
- Follows up with sites for trial invoices and ensures Clinical Trial Management System (CTMS) is accurately updated to allow the timely processing of Investigator Payments;
- Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives;
- Solves routine problems of limited scope and complexity following established policies and procedures;
- Seeks assistance for more complex issues.
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.
- 2+ years’ experience directing supporting clinical research;
- Working knowledge of GCPs, Trial Master Files, ICH guidelines is required;
- Read, write, and speak fluent English; fluent in host country language required;
- Experience with MS Office Suite (Word, PowerPoint, Excel, Project);
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines;
- Willingness to travel for job related activities if required (expected travel for this position is up to 25%).
Clinical Trials Manager
Posted: May 29, 2020
Current Location: Hayward, CA
read more >
This position is responsible for defining project scopes and estimating budgets, planning, directing, controlling project activities, managing people, resources, and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities. This position is also accountable for reporting of project progress status to Pulse Biosciences internal management. These activities may include but are not limited to managing projects with activities focused on clinical operations, data management, statistics, medical writing, subject randomization and study device supply management, administration of data monitoring and adjudication committees, as well as preparing device submissions to regulatory agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Collaborate with VP, Director, and Clinical Research Manager to set targets for clinical monitoring and clinical trials staff to ensure timeliness and compliance.
- Coordinate and supervise clinical team.
- Provide clinical team with training and guidance.
- Manage projects with activities focused on one or more of the following: clinical operations, data management, statistics, medical writing, subject randomization and device supply management, administration of data monitoring and adjudication committees, as well as preparing device submissions to regulatory agencies.
- Integrate information to define work scopes and estimate budgets, develop and manage cross-functional project work plans including resource requirements and utilization, budgets, quality deliverables and timelines.
- Manage all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH/GCP guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
- Ensure the timely initiation and completion of clinical study projects.
- Lead cross-functional project teams. Manage the planning, implementation, conduct and reporting of assigned projects within the established timelines and budgets, and with the quality and requirements necessary for regulatory approvals.
- Manage activities between Pulse Biosciences and study sites, and with various supporting groups or third-party vendors (e.g., central lab and other specialty labs) to ensure that all contractual obligations are met.
- Proactively track and manage the financial status against budget and reconcile expenses across sub-streams of activities.
- Proactively track and manage project tasks against timelines and hours spent/budgets, alert management when there are risks of having major deviations.
- Prepare project status reports and maintain accurate and current details. Present project status to internal and external stakeholders.
- Function as meeting facilitator for the meetings involving various internal and external participants.
- Function as facilitator of problem solving and conflict resolution.
- Communicate project action items and key decisions through timely minutes and follow up actions.
- Conduct “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
- Contribute and/or participate in the performance evaluation of staff who performed under the responsible projects.
- When required, this position may assist the organization in responding to and preparing for Request for Information and Request for Proposals for Investigator Initiated Studies, and subsequently defining work scopes and budgets, and performing contract administration activities.
- When required, perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.
- May provide support in Clinical Operations as required, such as the following:
- Assist in the development of study-specific training materials.
- Manage the process of setting up and maintaining the Trial Master File.
- Review/compile documentation for qualification of clinical sites. Support review of that documentation to ensure that those clinical sites comply with ICH/GCP and relevant local regulations.
- Assist with the preparation and negotiation of contracts with investigational sites and vendors.
- Assist with the preparation of summary reports and presentations for Board of Director Meetings.
QUALIFICATIONS / 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.
- Sc. or M.Sc. in life sciences or health related field.
- Minimum of 8 years’ clinical research experience within a medical device, or biotechnology setting.
- Minimum of 5 years’ project and people management experience is preferred.
- Experienced as a clinical trial monitor, initiating, monitoring, and closing out clinical trials will be desirable for Clinical Operations support tasks.
- Ability to travel a maximum of 35% of working hours may be required.
- Demonstrated understanding of cross-functional processes including clinical operations, statistics, data management, subject randomization and device supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
- Knowledge and understanding of ICH/GCP guidelines, FDA, Health Canada, and EMA regulations.
- Ability to define scopes and estimate budgets, plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines.
- Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
- Excellent interpersonal, oral and written communication skills. Demonstrated strong negotiation and presentation skills.
- Strong ability in problem-solving including conflict resolution.
Director of Regulatory Affairs
Posted: December 10, 2019
Current Location: Hayward, CA
read more >
This position will be responsible for strategic regulatory activities related to the development and implementation of regulatory strategies to support the submission and filing of multiple expanded and/or specific indications in Dermatology and Oncology medical device products in both US and targeted OUS 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, MDSAP, and applicable international regulatory compliance activities.
- Develop and implement competitive and effective FDA regulatory strategies for various Dermatology, General/Plastics and Oncology medical device /combination products including clinical and investigational studies, and identify potential risks associated with proposed strategies
- Manage and participate in the creation, review, editing, assembly and e-submission of regulatory documentation such as Pre-subs, 510ks, SIRs, Letter-to-Files, IDEs, and PMAs) including regulatory responses and agency face-to-face and/or teleconference interactions.
- Conduct the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience/follow-up 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 with sound statistics 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, investigational releases, 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.
- Adaptable team player with the ability to work cross-functionality.
- Bachelor's degree in a life sciences, engineering, or related discipline.
- 10 to 15 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, minimally invasive and open Surgical indications 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 with MDSAP regulations
- Experienced with both high-risk device and non-significant risk device classes (Class III/IIb/IIa/II)
Send resume to: firstname.lastname@example.org
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.