- University of Pennsylvania (Philadelphia, PA)
- …wellness programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist C Job Profile Title Clinical Research Regulatory ... information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA...information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA… more
- Novo Nordisk (Plainsboro, NJ)
- …to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks ... About the Department The Clinical , Medical and Regulatory (CMR) department...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
- University of Pennsylvania (Philadelphia, PA)
- …organizations (CROs), and the FDA , as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs ... the IRB, FDA and all applicable institutional regulatory review committees. In collaboration with clinical ...and ongoing protocol training/compliance meetings The Regulatory Affairs Specialist will also help Clinical Research… more
- Novo Nordisk (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs , Legal, Commercial, and other cross-functional stakeholders… more
- Fresenius Medical Center (Raleigh, NC)
- …be responsible for the direct supervision of various levels of Pharmaceutical Regulatory Affairs staff. **EDUCATION:** + Bachelor's Degree required; Advanced ... and other compliant alternatives to product team. + Facilitates clinical strategy development in providing regulatory guidance...This person should be a subject matter expert on Regulatory Affairs as it relates to HealthCanada.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …notifications are required. + Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other regulatory frameworks. + Work ... **Job Description Summary** As Staff Specialist Regulatory Affairs , you will have a...regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is currently recruiting for a Senior Regulatory Affairs Specialist for a 2-year contract opportunity with a leading molecular ... Associate, New Product Development **Pay rate:** $50-55/hour **Company:** Kelly(R) Science & Clinical **Overview** The Regulatory Affairs Senior Specialist… more
- Merck (Upper Gwynedd, PA)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …(INDDC), including conducting detailed reviews of submissions. + Oversees and manages the FDA regulatory approval process for IND/IDE submissions, acting as a ... Exciting opportunity at MSK: Join our team as aRegulatory Affairs Analyst! We're looking for a dynamic clinical...per months onsite + Reporting to the Associate Director, Regulatory Affairs Pay Range: $70,700.00 - $109,500.00… more
- University of Pennsylvania (Philadelphia, PA)
- …Summary he Associate Director of Regulatory Affairs will oversee regulatory strategy and compliance for clinical research initiatives within the Penn ... programs and resources, and much more. Posted Job Title Associate Director Regulatory Affairs (Immune Health Institute) Job Profile Title Associate Director,… more
- Philips (Bothell, WA)
- …right fit if:** + You've acquired a minimum of 7 years' experience in Regulatory Affairs within FDA regulated medical device/software (SaMD, SiMD) ... 62366-1 + You have a Minimum of a Bachelor's Degree (Required) in Regulatory Affairs , Biomedical Engineering, Clinical /Life Science or similar disciplines.… more
- Medtronic (Minneapolis, MN)
- …Class II/III medical devices + Experience with regulatory support of clinical trials + Experience with FDA requirements, guidance documents, Medical Device ... life support * Coronary artery bypass grafting (CABG) solutions The **Senior** ** Regulatory Affairs Specialist** is responsible for developing regulatory … more
- ThermoFisher Scientific (Greenville, NC)
- …crucial role in the development of novel and innovative medical devices?** The Regulatory Affairs Manager develops regulatory strategies and supports product ... **Job Description** Join Thermo Fisher Scientific Inc. as a Clinical Trial Reg Affairs Manager specializing in...as well as the preparation of marketing applications. The Regulatory Affairs Manager identifies and communicates potential… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Regulatory Affairs Principal for a 6-month contract opportunity with a leading molecular diagnostics company based ... contract **Pay rate:** $58-63/ hour. **Company:** Kelly(R) Science & Clinical **Overview** The Regulatory Affairs ...product launch (US, EU, WHO/PQ). + Authors and prepare regulatory submissions (US- FDA , IVDR, WHO/PQ) as required… more
- Amazon (Lockbourne, OH)
- …business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs , and internal auditors. Our ... Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …Executive Director might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC) for ... position you will build and lead a cell medicine regulatory affairs team and provide regulatory...management. + Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for… more
- Medtronic (Minneapolis, MN)
- …pre- clinical , clinical , approval and post-approval. Navigate worldwide regulatory requirements and adhere to regulations including FDA medical device ... this opening will close on - 11 Apr 2025 Position Description: Senior Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Responsible for… more
- Kelly Services (Bristol, TN)
- **Job Title** : Senior Associate, Regulatory Affairs **Location** : Bristol, Tennessee (100% on-site and relocation assistance provided) **Salary** : $90-105,000 ... dependent upon experience **POSITION SUMMARY:** Responsible for support of regulatory affairs activities under direction of department management. Activities may… more
- Medtronic (Minneapolis, MN)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and ... and review process + Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion - Neuroscience, combines ... pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (eg regulatory affairs fellowship, Health Authority, ad promo, etc.) + Preferred… more