{"id":945405,"url":"https://alion.io/job/neuropace-sr-regulatory-affairs-manager","title":"Sr. Regulatory Affairs Manager","company":{"id":679154,"name":"NeuroPace","domain":"neuropace.com","url":"https://alion.io/company/neuropace","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":78,"open_postings":3,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":67,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mountain View, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":207000,"max_usd":363000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":356},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 10993","optional":false},{"name":"Machine Learning","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-08-28T23:13:22Z","employer_posted_date":"2026-09-18","last_verified_at":"2026-11-04T13:27:59Z","board_verified":true,"closed_at":null,"days_open":67,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":67},"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.\nAt 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.\nWe 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. \nKey Responsibilities:\nImplements regulatory strategies for new and modified products to facilitate timely regulatory approval in support of business goals and objectives.\nAs a core team member on product development teams, provides regulatory feedback, guidance throughout the product development cycle, and coordinates team inputs for submissions.\nPartners with Clinical Affairs on the development of effective clinical trial strategies.\nManages 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).\nReviews and approves device labeling and promotional/advertising materials, including making recommendations to ensure compliance.\nDevelops and maintains positive relationships with regulatory agency reviewers throughout the total product life cycle.\nProvides regulatory training/mentoring to cross-functional teams.\nDevelops and implements departmental policies and procedures.\nAssists in establishing project priorities, allocating resources and workload, and in the development of department objectives in support of business objectives.\nApplies 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.\nGenerally, 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.\nStrategically, 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.\nSupervises department staff members, as assigned.\nRequirements:\nBachelor’s degree in a scientific or technical discipline required; advanced degree and/or professional certification(s) preferred.\n6-8 years' of regulatory affairs medical device industry experience required, with at least 3 years of people management preferred.\nThorough understanding and extensive experience with FDA regulations; PMA experience required. Experience with international regulations preferred.\nWorking understanding of highly technical and complex active implantable medical device systems, including hardware and software, is required.\nDemonstrated experience with the regulatory requirements for specialized technical disciplines, including cybersecurity, artificial intelligence, and machine learning preferred.\nExtensive knowledge of product development process and design controls, and an excellent grasp of change control and verification and validation requirements.\nProficient knowledge of clinical trial strategy, study design and related submissions.\nRegulatory project management experience required, including excellent project and time management skills and the ability to effectively manage multiple projects.\nExtensive 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.\nExcellent research, analytical, organizational and interpersonal skills, with ability to influence a variety of stakeholders.\n$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.\nNeuroPace 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)\nBenefits\nMedical, Dental & Vision Insurance\nVoluntary Life\n401K\nRSU\n529 plan\nESPP Program\nHealth & Wellness Program\nGenerous Paid Time Off plus eleven paid holidays\nFSA & Commuter Benefits\nNeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.\nSan 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)\nPRIVACY 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 .","description_format":"text","description_chars":6969,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-09-15T20:28:09Z"}],"visa":[],"liveness":{"score":34,"band":"fade","label":"Fading","p_open":1,"p_active":0.775,"p_room":0.44,"age_days":67,"expected_fill_days":67,"reasons":["conf:1","win:tail","crowd:"],"computed_at":"2026-11-04T06:34:25Z"},"pay":null,"html_url":"https://alion.io/job/neuropace-sr-regulatory-affairs-manager","json_url":"https://alion.io/job/neuropace-sr-regulatory-affairs-manager.json","meta":{"generated_at":"2026-11-04T18:13:48Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":28023,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":679154},"rest":"https://alion.io/mcp/rest/get_company?id=679154"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fneuropace-sr-regulatory-affairs-manager"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fneuropace-sr-regulatory-affairs-manager"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fneuropace-sr-regulatory-affairs-manager"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/neuropace-sr-regulatory-affairs-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fneuropace-sr-regulatory-affairs-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":945405}},{"tool":"search_jobs","arguments":{"company":"neuropace.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":945405},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}