- Chemours (Sacramento, CA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Meta (Burlingame, CA)
- …**Minimum Qualifications:** Minimum Qualifications: 8. 7+ years of industry experience in medical device regulatory affairs or related industry 9. ... 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 Lead… more
- Meta (Burlingame, CA)
- …scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. Experience ... a 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
- Abbott (Alameda, CA)
- … medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices , drugs and/or biologics including ... life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices , and/or… more
- Abbott (Alameda, CA)
- … medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....plus. . Experience with 510(k) applications, PMA supplements, US device regulations, and/ or with EU and other international… more
- Medtronic (Santa Rosa, CA)
- …+ Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry, + Or advanced degree with a minimum ... of 5 years of Regulatory Affairs experience. + Medical ...globally. + Experience performing advertising and promotion reviews/approvals for medical devices . + Experience engaging regulatory… more
- Medtronic (Los Angeles, CA)
- …+ Previous experience in Medtronic Regulatory Affairs + 10+ years experience in regulatory affairs in medical device industry or other highly regulated ... strategies for new and modified Class IIa & Class III devices and preparing and submitting regulatory submissions in the EU and supporting outside of US (OUS)… more
- Abbott (Santa Clara, CA)
- …providing strategic and predictable Regulatory Services in collaboration with the medical device business units that Leveraged Services team supports. **The ... on regulatory activities and works with the medical device business units that Leverage Services...experience in regulatory affairs; highly preferred with medical devices . + At least 5 years… more
- Edwards Lifesciences (Irvine, CA)
- …an impact:** + Provide high quality guidance and support to Edwards' on healthcare and medical device regulatory matters, including US and other medical ... potential legal risks. This role requires deep knowledge of global medical device -industry, including the regulatory landscape, authorities and frameworks,… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI),...medical or other technical fields and Class III medical device experience are preferred. + Ability… more