- Kelly Services (Gillette, WY)
- …and launching a state-of-the-art research laboratory dedicated to shaping the future of healthcare . As a **Senior FDA Regulatory Affairs Specialist** , ... regulatory teams to meet safety and efficacy standards. ** Regulatory and Compliance Expertise:** + Lead FDA ...experience in regulatory affairs, product development, or FDA submission leadership in a healthcare or… more
- Sanofi Group (Framingham, MA)
- …and roll-out of the Sanofi Quality Management System in line with US FDA cGMP regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi ... **Job Title:** Compliance Head- US FDA **Location** : Framingham, MA, Morristown, NJ **Job...Morristown, NJ **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the… more
- GE HealthCare (Chicago, IL)
- …product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best ... product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. + Prepares global … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the ... Guidance and SaMD related Guidance. + Knowledge of international regulatory requirements (eg, FDA QSR, ISO 13485,...and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum… more
- BeOne Medicines (San Mateo, CA)
- …**Essential Functions of the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically ... and advice on FDA interactions. + Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission… more
- IQVIA (Durham, NC)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... and consortia + Lead development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to PED + Contribute to the… more
- ThermoFisher Scientific (Frederick, MD)
- …requirements related to submissions and post market requirements, as required. + Leads regulatory interactions with the FDA to expedite query responses and gain ... training that can be applied across teams and divisions to improve understanding of regulatory requirements and the FDA . + Partners with leadership to develop… more
- Medtronic (Minneapolis, MN)
- …develop solutions to complex US promotional issues. + Interact directly with FDA and/or indirectly with international regulatory agencies on most ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...feedback and on-going support to product development teams for regulatory issues and questions. + Prepare FDA ,… more
- RWJBarnabas Health (West Orange, NJ)
- …years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + Comprehensive knowledge ... Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **Associate Director, US Advertising & Promotion Regulatory Review** **Takeda Pharmaceutical** **USA-MA-Virtual** **About the role:** Join ... Takeda as an Associate Director, US Advertising & Promotion Regulatory Review. Where you will be working on the...be empowered to serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion… more
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