- Programmable Medicine Operatin (Redwood City, CA)
- …meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and ... on developing novel nanomedicines, HD therapeutics (HDTs), to treat unmet medical needs in ophthalmology, neurology, inflammatory diseases, and neuro-oncology. Our… more
- Tools for Humanity (San Francisco, CA)
- …supporting the Worldcoin open-source protocol by managing Tools for Humanity's legal affairs globally. We collaborate across the company to advance the blockchain ... and enhance our products, including the Orb (our hardware device ), World ID, World App, and World Chain. We...with the Worldcoin Foundation and other partners to ensure regulatory compliance in areas such as securities, AML/CFT, consumer… more
- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Meta (Burlingame, CA)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... **Summary:** We're seeking a regulatory affairs specialist to join our medical ...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Stryker (Fremont, CA)
- …with a solid understanding of regulatory standards and practices. + Exposure to Medical Device Regulatory Affairs or Engineering through coursework, ... Fremont, CA or Salt Lake City, Utah as a Regulatory Affairs Specialist.** At Stryker, we're driven...experience working with US Class II and Class III medical devices. + Demonstrates strong analytical and writing skills,… more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site ... glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for...Scientific writing experience. + Solid understanding of the EU Medical Device Regulation (MDR - Regulation (EU)… more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Manager - APAC** position will work on-site at… more
- Abbott (Pleasanton, CA)
- …Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus + ... treatment. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist** to join our team...+ Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies as applicable, for the designated program to support clinical trials where necessary, and… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge... regulations and/or experience with EU and other international medical device regulations and submissions. + Ability… more
- Abbott (Pleasanton, CA)
- …discipline + 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry + Familiar with relevant US/ EU ... working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that...fingersticks. **WHAT YOU'LL DO** We are recruiting for a ** Regulatory Affairs Specialist II** to join our… more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out ... As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support...in a timely manner. + Experience working in the Medical Device industry. + Certification is a… more
- Abbott (Alameda, CA)
- …**Qualifications** + 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... US Drug regulations or with EU and other international medical device regulations and submissions. + Familiar...device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices, drugs and/or… more
- Abbott (Alameda, CA)
- …Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... regulations, and/ or with EU and other international medical device regulations and submissions. . Familiar...device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality… more
- Stryker (Fremont, CA)
- …live out Stryker's mission to make healthcare better. **Opportunities Available** As a Regulatory Affairs (RA) intern at Stryker, you will gain exposure to ... insight into the collaborative design and development process + Support post-market regulatory reporting projects that help monitor device performance and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …goals, and results to team members across functions and departments, including device development, packaging, quality, regulatory affairs and manufacturing. ... + Experience in the pharmaceutical or biotechnology industry is preferred + Medical device or combination product experience is preferred + PMP certification is… more
- J&J Family of Companies (Santa Clara, CA)
- …reports, and regulatory submissions. + As needed, assist in the Medical Affairs review of advertising/promotional/education material. + Support the Clinical ... and scientific information while adhering to legal, compliance and regulatory requirements. The Principal Medical Sciences Specialist...minimum of 8 years of relevant Medical Affairs experience in the Medical Device… more
- Abbott (Pleasanton, CA)
- …from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. + Medical device industry experience. + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Roche (Pleasanton, CA)
- …with expertise in Companion Diagnostics. + Knowledge in IVD, Pharmaceutical, and /or Medical Device industry; Regulatory Compliance, Federal cGMP's and ... ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to...you will be a member of the companion diagnostics Regulatory Affairs Leadership team. In this position,… more
- Abbott (Pleasanton, CA)
- …budget and resources) by working closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Regulatory Affairs , Medical Affairs , ... a seasoned leader to join our Global Clinical and Regulatory Affairs team within the Heart Failure...data science teams and operating in a highly cross-functional medical device environment desirable. Global experience preferred.… more
