- 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
- 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
- Oura (San Francisco, CA)
- … affairs, or a related field; advanced degree preferred. + 8+ years of regulatory affairs experience in medical devices , digital health, or wearable ... of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key...external audits. + Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. +… more
- Envista Holdings Corporation (Brea, CA)
- …**QUALIFICATIONS:** + Bachelor's Degree (BA/BS) from four-year college/university + 2+ years of regulatory affairs experience in medical devices or other ... regulated industry, **or** Master's Degree with 1+ years of regulatory affairs experience in medical devices...regulated industry. + Strong working knowledge of the European Medical Device Regulation (EU MDR), including demonstrated… more
- Canon USA & Affiliates (Sacramento, CA)
- …Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum ... ** Regulatory Affairs Specialist - Post Market - req1434**...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… 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 ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....products. Manage staff whose team is responsible for filing Medical Device Reports to the FDA (US),… more
- Abbott (Santa Clara, CA)
- …in a broader enterprise/cross-division business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …of five (5) years of Regulatory Affairs experience in the medical device industry required + Strong prioritizing, interpersonal, communication, and ... crucial role in supporting Medication Management Solutions (MMS) dispensing products, including non- medical devices , medical devices , associated… more
- Actalent (Valencia, CA)
- …and post-market compliance of medical devices , including Software as a Medical Device (SaMD). The role involves managing a team of regulatory ... years of regulatory affairs experience in the medical device industry. + At least 2...820, 807, 814, 812, EU MDR 2017/745, Health Canada Medical Devices Regulations, TGA and PMDA requirements.… 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 regulatory submissions. + Support bringing novel medical devices from concept to release, manage… more