- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Medtronic (Irvine, CA)
- …Medical Device Experience:** Minimum of 4 years of relevant experience in medical device regulatory affairs . + **510(k) Submission Experience:** ... or university required; advanced degree with a minimum of 2 years of experience in medical device regulatory affairs is a plus. + ** Regulatory … more
- GRAIL (Menlo Park, CA)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …is specifically focused on regulatory affairs for Software as a Medical Device (SaMD) products. The candidate will need deep expertise in FDA ... processes (ISO 14971) and cybersecurity for medical device . **Preferred Qualifications:** + Regulatory Affairs... medical device . **Preferred Qualifications:** + Regulatory Affairs Certification (RAC) + Experience with… more
- Medtronic (Santa Rosa, CA)
- …degree in a technical discipline + Minimum of 7 years of direct Regulatory Affairs experience within the medical device or other regulated industry, + Or ... degree with a minimum of 5 years of Regulatory Affairs experience. + Medical device industry experience with Class I/II/III/IV software products. **Nice… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Regulatory Affairs , Device works with internal and external ... partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for … more
- J&J Family of Companies (Santa Clara, CA)
- …to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory Affairs Manager combines knowledge ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease… more
- Caldera Medical (Westlake Village, CA)
- …Sciences, Biomedical Engineering, or a related field. * 5-7 years of regulatory affairs experience in the medical device industry. * Strong understanding ... Sr. Regulatory Affairs Specialist 100% ONSITE in... Regulatory specialist, you will develop and implement medical device regulatory strategies to… 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...is helpful. + At least 5 years' experience in regulatory affairs ; highly preferred with medical… more
- Abbott (Alameda, CA)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support… more
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