New · posted Oct 15
NeuroPace · Medical Devices
Senior Regulatory Affairs Manager
- Mountain View, CA
- Hybrid
- Full-time
- Manager
Open until filled
The role
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.
What you need
- 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.
What you'll do
- 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.
Pay and benefits
$160,000 – $190,000 a year
Employer provided$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.
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
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)
Where you'll work
Mountain View, CAHybridOpen in Maps (opens in a new tab)
More jobs in Mountain View, CAEqual opportunity, accessibility and legal noticesNeuroPace's statements, word for word
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)
NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
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 [email protected].
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in California14 roles publishing pay
Manager roles in the US47 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $160,000 | — | $190,000 |
| California (middle half) | $159,000 | $171,000 | $179,500 |
| All US (middle half) | $146,750 | $162,500 | $177,750 |
This role: NeuroPace's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not NeuroPace's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions9
- Collaboration and leadership6
- Data and digital systems4
- Documentation and SOPs3
- Quality systems and risk3
- GMP and compliance2
- Lab testing and methods1
- Investigations and CAPA1
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
NeuroPace on Regulatory Jobs
- 1
- Open roles
- 1
- Distinct roles
- 1
- Locations
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Senior Regulatory Affairs Manager at NeuroPace
Open until filled. $160K–$190K a year, employer provided.