Sr. Regulatory Affairs Manager

NeuroPace

Mountain View (CA)

Hybrid

USD 160,000 - 190,000

Full time

14 days+

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Benefits offered by this job

Medical, Dental & Vision Insurance

401K

RSU

ESPP Program

Health & Wellness Program

Generous PTO & holidays

FSA & Commuter Benefits

Job summary

NeuroPace, based in Mountain View, CA, seeks a Senior Regulatory Affairs Manager to lead regulatory support for new product development, sustaining, and clinical study projects for a fully implantable US Class III medical device system. This hybrid role requires involvement 2-3 days in the Mountain View office.

You will supervise regulatory staff, drive submissions (PMA/IDE), and ensure compliance across lifecycle, partnering with clinical affairs, biocompatibility, software, and cybersecurity

Qualifications

Bachelor’s degree in a scientific or technical discipline required.
6-8 years regulatory affairs medical device industry experience; 3+ years people management preferred.
Thorough understanding of FDA regulations; PMA experience required; international regulations a plus.
Working knowledge of active implantable medical devices (hardware/software) is required.
Experience with cybersecurity, AI, and ML regulatory aspects is preferred.
Strong project management, written/oral communication, and cross-functional collaboration.

Responsibilities

Develop regulatory strategies for new/modified products to enable timely approvals.
Provide regulatory feedback throughout product development lifecycle.
Coordinate regulatory submissions (PMA, IDE, 30-day notices, annual reports).
Review labeling and promotional materials for compliance.
Build relationships with regulatory reviewers across product lifecycle.
Mentor teams and develop departmental policies and procedures.
Align Quality/Regulatory perspectives across the Total Product Lifecycle.

Skills

Regulatory affairs

FDA regulations

PMA experience

Project management

Clinical trial strategy

Regulatory submissions

Communication

Cybersecurity/AI/ML awareness

Education

Bachelor’s degree in science/engineering

Advanced degree or professional certification preferred

Tools

MS Office

Adobe

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.

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 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 inthe 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.

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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)

Benefits