- Kelly Services (Norcross, GA)
- …area for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / Medical Devices Location: Norcross, GA Industry: ... Regulatory Affairs professional to manage pre-market regulatory activities for medical devices ,...* Knowledge of FDA 21 CFR 820, Health Canada Medical Device Regulations, MDSAP, and exposure to… more
- Abbott (Plymouth, MN)
- …etc.), math, engineering, or medical fields. + Master's degree in Regulatory Affairs . + Regulatory experience with capital equipment including ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …+ 5+ years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …. 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices … more
- IQVIA (New York, NY)
- …data, etc.), HCP engagement by life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would also ... **Manager, Medical Affairs Strategy** **Overview** IQVIA is...diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies as well… more
- BD (Becton, Dickinson and Company) (Tempe, AZ)
- …+ Medical writing experience + Experience in cross-functional collaboration with regulatory , clinical, marketing, medical affairs , HEOR, and R&D + ... platforms to support compliant scientific communications + Other incidental duties: represent Medical Affairs in various internal and external programs. Assist… more
- embecta (Parsippany, NJ)
- …discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + Must have ... in both the US and Europe, and related regulatory affairs activities to ensure compliance with...current knowledge of the US and European Medical Device regulations. + Demonstrated success in… more
- Bayer (Washington, DC)
- …As the Director of Regulatory Affairs , you will represent our medical device regulatory team within the Molecular Imaging platform. This pivotal ... required + Direct professional experience in Regulatory Affairs within the medical device ... device industry, with significant experience involving medical devices pumping systems, or software-driven electromechanical… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …field acceptable with appropriate level of experience. + Minimum 1-2 years Regulatory Affairs experience in medical device or in vitro diagnostic ... devices . Under the mentorship of the Manager of Regulatory Affairs , the position will provide technical...collaboration and teamwork skills. + Working knowledge of US medical device regulations, 21 CFR 820 Quality… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and develop **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** ... Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF… more
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