Director of Regulatory Affairs
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: email@example.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.