- Meta (Burlingame, CA)
- …investigation **Minimum Qualifications:** Minimum Qualifications: 8. 7+ years of industry experience in medical device regulatory affairs or related ... commercialized in the smart wearables and software as a medical device direct to consumer space. You... landscapes and driving successful product registrations. **Required Skills:** Medical Devices , Regulatory Affairs… more
- Medtronic (Irvine, CA)
- …relevant experience + Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs **This is not a remote position** ... **Nice To Have** + 4 years of experience in medical device regulatory affairs + Excellent technical knowledge of medical products and understanding… more
- Abbott (Santa Clara, CA)
- …business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Other duties as assigned. **Requirements** + Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; ... aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease...for Shockwave Medical , Inc. (SWMI). The Sr. Regulatory Affairs Specialist combines knowledge of scientific,… 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. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- Medtronic (Santa Rosa, CA)
- …degree in a technical discipline + Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry, + Or ... a minimum of 5 years of Regulatory Affairs experience. + Medical device ...globally. + Experience performing advertising and promotion reviews/approvals for medical devices . + Experience engaging regulatory… more
- Abbott (Alameda, CA)
- …+ 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices , drugs and/or biologics including… more
- Abbott (Alameda, CA)
- …. 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices … more
- Caldera Medical (Westlake Village, CA)
- …, business or related field. * 10+ years of progressive experience in regulatory affairs within the medical device industry. * Proven track record with ... Director of Regulatory Affairs ONSITE in Westlake Village,...regulatory strategies for Class I, II and III medical devices across all stages of the… more
- Oura (San Francisco, CA)
- …or a related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices , digital health, or wearable technology, ... of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play...external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. +… more
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