- Fujifilm (Sacramento, CA)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...other applicable laws. + Keep abreast of legislative and regulatory changes with respect to healthcare and other relevant… 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 device industry experience with Class I/II/III/IV software products. **Nice To Have:** + Direct … more
- 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...device direct to consumer space. You will lead regulatory strategy development, submissions, and approvals for United States… 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 ... **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
- 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...and leadership experience to support the medical device business units with their regulatory submissions.… more
- US Tech Solutions (San Bruno, CA)
- …of Quality Concepts (eg, Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA, Notified ... + Managing cross-functional or cross-team projects to bring regulated medical device products to market. + Ensuring...and mentoring to engineers to ensure audit readiness and regulatory submissions. + Support bringing novel medical … 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
- Abbott (Alameda, CA)
- …+ Minimum of 5 years of experience in Quality Systems, Quality Assurance and/or Regulatory Affairs + Medical device industry or other regulated environment ... products. Manage staff whose team is responsible for filing Medical Device Reports to the FDA (US),...Function as a representative during audits, inspections, assessments by regulatory agencies, eg FDA for the medical … more
- Medtronic (Irvine, CA)
- …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 of relevant… more