- Gilead Sciences, Inc. (Foster City, CA)
- …to accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination ... regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with… more
- Oura (San Francisco, CA)
- …quality system, including external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. + Experience with privacy ... tracking. We view Oura Ring as a clinical grade device in a consumer package rather than as a...related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices, digital… more
- Abbott (Sylmar, CA)
- …requirements + Review and approve advertising and promotional items to ensure regulatory compliance + Ensure external communications meet regulations + Develop, ... medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific… more
- Abbott (Santa Clara, CA)
- …submission and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality, ... software, vessel closure devices and peripheral stents. This **Principal Regulatory Affairs Specialist** position is an onsite opportunity working...in a timely manner. + Experience working in the Medical Device industry. + Certification is a… 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 ... specialists + Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture. + Represent… more
- Kelly Services (Petaluma, CA)
- …degree in Engineering or related field (advanced degree preferred). + 5+ years of regulatory or compliance experience in medical devices, pharmaceuticals, or ... ** Regulatory Engineering Specialist** **Location:** Petaluma, CA (Onsite) **Employment...the Opportunity** Kelly Engineering is partnering with a fast-growing medical device and pharmaceutical company that is… more
- Abbott (Santa Clara, CA)
- …submission and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality, ... software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working...in a timely manner. + Experience working in the Medical Device industry. + Certification is a… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …direct professional experience ( Regulatory ) in increasingly responsible positions in the medical device field and seven (7) years of management experience + ... possible** ! BD is one of the largest global medical technology companies in the world. _Advancing the world...to key strategic decisions impacting the development of global regulatory compliance policies, processes, and procedures +… more
- Grifols Shared Services North America, Inc (San Carlos, CA)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive continuous ... RAPS RAC certification preferred + Minimum of 5 years of strong Regulatory Affairs/ Compliance experience in medical devices + Experience with end-to-end SAMD… more