- 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
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- Abbott (Santa Clara, CA)
- …legislation, regulations, and guidances + Communicates with internal groups to share updates on regulatory changes as it pertains to the FDA + Utilizes technical ... Abbott is a global healthcare leader that helps people live more fully...and maintenance in regulated environments. + In-depth knowledge of regulatory frameworks (eg, FDA , EMA, ISO 13485,… 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
- 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
- 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …**Preferred Qualifications:** + Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other ... global regulatory agencies and experience negotiating with regulatory authority personnel (eg FDA , Notified Bodies) preferred + Must demonstrate ability to… 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
- Lilly (Indianapolis, IN)
- …across GRA** + Partnering with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising ... in US Regulatory Advertising and Promotion + Comprehensive knowledge of FDA procedures and practices across Review Divisions and OPDP (CFR guidelines, Guidances,… 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
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