- Oracle (Sacramento, CA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Medtronic (Santa Rosa, CA)
- …profile._ + Bachelor's degree required with a + Minimum of 4 years of experience in medical device regulatory affairs experience + Or Advanced degree ... approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device...heart valve products + Experience with Software as a Medical Device + RAC Medical … more
- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies as applicable, for the designated program to support clinical trials where necessary, and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Bausch + Lomb (Sacramento, CA)
- …+ Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device , cosmetics or ... and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative...**We offer competitive salary & excellent benefits including:** + Medical , Dental, Eye Health, Disability and Life Insurance begins… more
- Fujifilm (Sacramento, CA)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Veterans Affairs, Veterans Health Administration (Martinez, CA)
- …in the development, coordination and review of directives, white papers, Medical Center Memorandum, service support agreements, standard operation procedures, policy ... program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) As a condition of...analytical and evaluation methods and thorough understanding of how regulatory programs are administered to select and apply program… more
- Cardinal Health (Sacramento, CA)
- …& Filing + Quality Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance ... provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to...+ Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Actalent (Sacramento, CA)
- …will play a crucial role in ensuring the quality and compliance of new medical device products throughout their development lifecycle. You will be responsible ... plans and conducting risk reviews. Essential Skills + Experience with the medical device product development lifecycle, including risk management and… more
- Edwards Lifesciences (Oakland, CA)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive… more
- Edwards Lifesciences (Sacramento, CA)
- …Knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more
- Danaher Corporation (West Sacramento, CA)
- …minimum of 6 years marketing or selling healthcare IT and/or Software as a Medical Device solution to hospital buyers with deep understanding and experience with ... many internal and external constituents including physicians and laboratorians, clinical/ medical /scientific affairs , business units, market access, and… more