NeuroPace→
Sr. Regulatory Affairs Manager at NeuroPace in Mountain View, CA
Job Description
Based in Mountain View, CA., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differential RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source.
At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.
- Implements regulatory strategies for new and modified products to facilitate timely regulatory approval in support of business goals and objectives.
- As a core team member on product development teams, provides regulatory feedback, guidance throughout the product development cycle, and coordinates team inputs for submissions.
- Partners with Clinical Affairs on the development of effective clinical trial strategies.
- Manages and prepares regulatory submissions of varying levels of complexity (including PMA 180-Day Supplements, Real Time Review Supplements, 30-Day Notices, Annual Reports and IDE submissions).
- Reviews and approves device labeling and promotional/advertising materials, including making recommendations to ensure compliance.
- Develops and maintains positive relationships with regulatory agency reviewers throughout the total product life cycle.
- Provides regulatory training/mentoring to cross-functional teams.
- Develops and implements departmental policies and procedures.
- Assists in establishing project priorities, allocating resources and workload, and in the development of department objectives in support of business objectives.
- Applies Total Product Lifecycle (TPLC) and Quality System principles across the product lifecycle, exercising sound generalist judgment to identify emerging risks and issues, and knowing when and which subject matter expert (e.g., clinical, biocompatibility, software/cybersecurity, human factors, sterilization) to engage for deeper technical input.
- Generally, maintains a broad, working knowledge across TPLC and Quality System domains (design controls, risk management, post-market surveillance, CAPA) sufficient to identify issues early and route them to the appropriate subject matter expert.
- Strategically, works with functional leadership to integrate Quality and Regulatory perspectives across the Total Product Lifecycle, translating cross-functional technical input into cohesive regulatory strategy while recognizing the boundaries of one's own expertise and proactively engaging the right subject matter experts (e.g., biocompatibility, software, clinical, human factors) at the right time.
- Supervises department staff members, as assigned.
- Bachelor’s degree in a scientific or technical discipline required; advanced degree and/or professional certification(s) preferred.
- 6-8 years' of regulatory affairs medical device industry experience required, with at least 3 years of people management preferred.
- Thorough understanding and extensive experience with FDA regulations; PMA experience required. Experience with international regulations preferred.
- Working understanding of highly technical and complex active implantable medical device systems, including hardware and software, is required.
- Demonstrated experience with the regulatory requirements for specialized technical disciplines, including cybersecurity, artificial intelligence, and machine learning preferred.
- Extensive knowledge of product development process and design controls, and an excellent grasp of change control and verification and validation requirements.
- Proficient knowledge of clinical trial strategy, study design and related submissions.
- Regulatory project management experience required, including excellent project and time management skills and the ability to effectively manage multiple projects.
- Extensive experience in the preparation of high-quality regulatory submissions. Highly developed written and oral communication, technical writing and editing skills and proficiency with Microsoft Office and Adobe.
- Excellent research, analytical, organizational and interpersonal skills, with ability to influence a variety of stakeholders.
Benefits
- Medical, Dental & Vision Insurance
- Voluntary Life
- 401K
- RSU
- 529 plan
- ESPP Program
- Health & Wellness Program
- Generous Paid Time Off plus eleven paid holidays
- FSA & Commuter Benefits
NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
San Francisco and Los Angeles applicants: The Company will consider for employment qualified applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance in Hiring Ordinance or the San Francisco Fair Chance Ordinance (as applicable)
PRIVACY NOTICE: NeuroPace takes its responsibility to protect your personal information seriously, and it uses reasonable safeguards to avoid unauthorized use or disclosure of it, and inadvertent loss or impermissible alteration of it. NeuroPace complies with all applicable federal and state laws and regulations that govern the handling of your personal information. If you would like more detailed information on NeuroPace’s privacy policies, please refer to neuropace.com/privacy/ for reference. NeuroPace retains candidate resumes and applications in its files for future reference and/or consideration for other available job postings. If you do not wish for your resume and applications materials to be retained in NeuroPace files, or wish to obtain a listing of any personal information that NeuroPace has stored about you, please contact us at privacy@neuropace.com.