- GRAIL (Boise, ID)
- …products with the FDA and/or global health authorities. Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries. Regulatory affairs and IVD … more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …Minimum Requirements: Bachelor's degree Minimum 5 years of strong Regulatory Affairs experience in the medical device and/or in vitro diagnostic and/or ... This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy...review of procedures and systems designed to support the regulatory processes, and address global regulatory… more
- Dentsply Sirona (Milford, DE)
- …Years and Type of Experience 5(+) years of experience in regulatory affairs , preferably in the medical device industry. Experience with leading regulatory ... enhancing business relationships. Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring,… more
- Meta (New York, NY)
- …discipline or equivalent work experience 3+ years of industry experience in medical device regulatory affairs or related industry Experience working with ... Summary: We're seeking a regulatory affairs specialist to join our...to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You… more
- Kelly Services (Norcross, GA)
- …to offer a direct hire opportunity in the Norcross, GA area for a Principal, Regulatory Affairs (Transfusion). Principal, Regulatory Affairs - IVD / ... the Role We are seeking a highly skilled Principal, Regulatory Affairs professional to manage pre-market ...including in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA, Health… more
- Stryker (Minneapolis, MN)
- …live out Stryker's mission to make healthcare better. Opportunities Available ? ? As a Regulatory Affairs Intern, you will gain exposure to regulatory and ... legal frameworks, requirements, and processes that guide medical device development and compliance. In this role, you will support activities such as gathering and… more
- Lundbeck (Deerfield, IL)
- …Medical Affairs experience in the pharmaceutical, biotech or medical device industry. Minimum 2+ years' experience with contribution to medical strategy ... Director Medical Affairs , Rare Epilepsies Evidence Generation Requisition ID: 7165...the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With… more
- Bayer (Whippany, NJ)
- …global regulatory project goals from development through life cycle; Represents Global Regulatory Affairs on assigned global Project Teams; ... minds to make a real difference, there's only one choice. Director Global Regulatory Strategy (Molecular Imaging, Pharmaceuticals) The position is responsible… more
- Lilly (Durham, NC)
- …EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issues Works with numerous ... include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs Additional Preferences: Broad knowledge of GMPs… more
- Cardinal Health (Phoenix, AZ)
- …myriad of capacities, including: Global Regulatory Strategy Development Global Regulatory Affairs Chemistry Manufacturing and Controls Development ... and medical device companies get their products to market. Our regulatory and product development strategies are designed to reduce the risk of failure… more
