We are currently seeking a
Senior Regulatory Affairs Manager to join our team. This is a hybrid position based in the Mountain View, CA office 2-3 days a week. This individual will be responsible for regulatory support for new product development, sustaining, and clinical study projects and related submissions for a highly technical and complex active implantable US Class III medical device system.
Key Responsibilities:- 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 developmentcycle, 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.
Requirements:- 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.
$160K-$190K Base Compensation - Compensation will be determined based on several factors, including but not limited to skill set, years of experience, and geographic location.
#LI-Hybrid
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
