Director, Regulatory Affairs - Implantable Neurotech
Epia Neuro
Epia Neuro is seeking a full-time Director of Regulatory Affairs in Alameda, California. This role entails leading the regulatory strategy for Class III implantable neurotechnology, reporting directly to the CEO. The ideal candidate will have extensive FDA experience and a strong background in medical devices, particularly with Class III technologies. The position offers competitive salary and benefits, including healthcare coverage and generous vacation policy. Join us in our mission to enhance patient independence through innovative neurotechnology. #J-18808-Ljbffr Epia Neuro
- ...living with neurological conditions. Its platform integrates implantable neural interfaces, adaptive algorithms, and assistive... ...growing aging population. The Role We’re looking for a Director of Regulatory Affairs for our office in Alameda, California who wants to lead,...SuggestedFull timeWork at office3 days per week
- ...We are recruiting on behalf of a global clinical stage biotech who are looking to hire an Associate Director Regulatory Affairs to join their team on a permanent basis. Working onsite in San Francisco 3 days per week, the ideal candidate will bring small molecule experience...SuggestedPermanent employment3 days per week
- ...Director, Regulatory CMC (Hybrid – San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company with... ...individual will serve as a key interface between Regulatory Affairs, CMC, Quality, Technical Operations, and external partners...Suggested
$148.7k - $297.3k
The Opportunity This Associate Director Regulatory Affairs will work on‑site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life‑changing products that provide accurate data to drive...Suggested- ...therapies for people with degenerative retinal diseases independent of genetic mutation. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs will play a critical role in leading and executing global regulatory strategy for our clinical-stage...Suggested
$175k - $195k
...due to a disability, contact this employer to ask for an accommodation or an alternative application process. Associate Director, Regulatory Affairs, CMC Full Time Professional Berkeley, CA, US 4 days ago Requisition ID: 1002 Salary Range: $175,000.00 To $195,000.00 Annually...Full time$124.5k - $177k
Regulatory Affairs Strategy Manager (Oncology) page is loaded## Regulatory Affairs Strategy Manager (Oncology)locations: Alameda, CAtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR6552**SUMMARY/JOB PURPOSE:**Responsible for managing and maintaining...For contractorsLocal areaFlexible hours- A leading biotech company in Alameda is seeking an Associate GCP/GLP QA Director. This role focuses on driving consistency in QA systems within the Clinical QA team and involves responsibilities such as managing deviations and providing compliance guidance. The ideal candidate...
- ...status, we need someone who can build a world-class compliance and regulatory function. We're well-funded and backed by top investors,... ...What You'll Do As our Head of Compliance & Regulatory Affairs , you will report directly to our General Counsel, Peter Skaliy...Immediate start
$133k - $189k
...to enhance quality standards and operational efficiency. ESSENTIAL DUTIES/RESPONSIBILITIES Manage inspection logistics to support regulatory inspections, third‑party audits, and mock inspections at Exelixis, including notification process, logistics team, inspection...Contract workWork at officeLocal areaFlexible hours- ...is a national staffing firm and we are currently seeking a Regulatory Specialist for a prominent clientof ours. This position is located... ...to permanent. Required: ~5+ years of regulatory affairs experience ~ Medical Device regulatory affairs experience...Hourly payPermanent employmentContract work
$100k - $200k
...exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions... ...Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ~ Experience with either 510(...Shift work$100k - $200k
...best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This Principal Regulatory Affairs Specialist - APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We're focused on...For contractorsShift work- ...Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S... ...of international product registrations and related regulatory affairs activities, including execution of procedures and systems...
- A global healthcare leader is seeking a Regulatory Affairs Manager for their international compliance operations in Alameda, CA. The role involves providing end-to-end support for regulatory activities, ensuring compliance with FDA and international regulations. Candidates...
$80 - $100 per hour
...Hybrid for local candidates Hours: 40.0 Responsibilities Provide compliance oversight for the Global Patient Safety (GPS) and Regulatory Affairs (RA) functions, with a focus on Regulatory Affairs activities. Monitor, assess, and communicate performance against key...Contract workTemporary workFor contractorsLocal areaRemote work- About the Company Atomus' mission is to provide world class cybersecurity for the world’s most critical organizations. We build security compliance software delivered as managed services sold directly, with relevant professional services and support. Examples of our commercial...Full time
$210k - $250k
...leading biopharmaceutical company in Alameda, CA is seeking a Director of Quality Assurance. This role is responsible for leading quality... ..., ensuring compliance with GMP standards, and overseeing regulatory adherence. Ideal candidates have 15+ years in quality management...$148.5k - $209.5k
Assoc Scientific Regulatory Writing Director page is loaded## Assoc Scientific Regulatory Writing Directorlocations: Alameda, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR6365**SUMMARY/JOB PURPOSE** **(Basic purpose of the job):**Leads content development...Contract workWork at officeLocal areaFlexible hours$100k - $200k
.... The Opportunity This Principal International Regulatory Operations Specialist will work on-site at our Alameda, CA location... ...~ Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) ~2-3 years of experience in...WorldwideShift work$250k
...across the organization Establish structured processes for tracking, escalation, and resolution of compliance matters Oversee regulatory filings, documentation, and ongoing compliance obligations Advise on key regulatory requirements impacting investment advisers...- A leading biotech company in Alameda, California, is seeking an Assoc Scientific Regulatory Writing Director to lead the development of regulatory documents. This role requires extensive experience in the biotech/pharmaceutical industry and a strong understanding of regulatory...
- A progressive company based in California seeks a Recruiting and People Ops Manager. This role is vital for enhancing employee experience, managing People Operations, and ensuring compliance. You will oversee recruiting processes, partner with hiring managers, and maintain...
- ...payer/provider convenings. Monitor the evolving policy and regulatory landscape (e.g., CMS TEAM mandate, BPCI-A successors, ACO REACH... ..., or equivalent). Prior experience as a CMO, VP of Medical Affairs, Chief Quality Officer, or equivalent senior clinical...Full timeRemote workRelocation
$114k - $228k
...We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.**The Opportunity**This **Regulatory Affairs Manager - International Compliance Operations** will work on-site at our Alameda, CA location in the Diabetes Care Division....For contractorsWork experience placementWorldwide- ...biotechnology company located in Alameda, CA, seeks an Executive Director, GCP/GVP QA, to lead the implementation of quality assurance... ...bring extensive experience in the pharmaceutical industry and a deep understanding of regulatory requirements. #J-18808-Ljbffr Exelixis
- Company Description We are building the vertically integrated, distributed utility for hyperscalers. While legacy turbine manufacturers are sold out for the next half-decade, AI data centers are bleeding millions per day on idle compute. We wedge into this market with...Full timeRelocation
- Exelixis is seeking an Associate Director, Stability Management to lead stability programs for both commercial and clinical drug products. This role includes managing staff, establishing stability policies, and overseeing contract laboratories. The ideal candidate will...Contract work
$195k - $250k
...standards of safety, performance, and regulatory compliance from concept through commercial... ...files. Partner with Regulatory Affairs to support submissions and ensure compliance... ...leadership in developing Class III implantable devices and/or drug–device combination...Contract workHome officeFlexible hours$246k - $349.5k
Senior Director, Clinical Operations Compliance Management (Biotechnology/Oncology) page is loaded## Senior Director, Clinical Operations... ...understanding of the relevant external scientific, legal and regulatory environment.* Prior experience leading a team.**Knowledge,...Work at officeLocal areaFlexible hours
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