- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...including drug device /combination products and software as medical device platforms.- Reviews and resolves issues… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory experience ... About the Department The Clinical, Medical and Regulatory (CMR) department at...agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …failures.Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for ... retention, testing and retesting of samplesProject Team Participation: Provide device -specific regulatory insight/guidance during CDx Indication Team Working… more
- Leica Biosystems (Boston, MA)
- …about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs , finance, NNGlobal, and other ... plan for devices for the brand portfolio (eg, single dose device , PDS290, pre-filled syringe), and maintaining strategic oversight of device -related elements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... of a quality strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Engagement, Medical Affairs , Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs , Integrated ... with start-ups, technology companies, and other external partners across diagnostics, medical devices , digital health, digital therapeutics, and data analytics… more
- Novo Nordisk Inc. (Detroit, MI)
- …Incumbents have a deep scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between ... About the Department The Clinical, Medical and Regulatory (CMR) department at...to deliver scientific value proposition of NNI's products and devices to key customers and formulary decision makers. Delivers… more
- Novo Nordisk Inc. (San Francisco, CA)
- …Incumbents have a deep scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between ... About the Department The Clinical, Medical and Regulatory (CMR) department at...to deliver scientific value proposition of NNI's products and devices to key customers and formulary decision makers. Delivers… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with cross-functional teams, including Field Sales, Marketing, Strategic Partnership and Engagement, Medical Affairs , Market Access and Public Affairs ... (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs , Compliance and other relevant NNI departments to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of the pharmaceutical industry including marketing, medical , access, public affairs , compliance, legal and regulatory as well as the healthcare ... role will closely partner with Field Sales, Market Access, Commercial Excellence, Medical Affairs , Strategic Partnerships and Engagement, Customer Experience and… more
- Beckman Coulter Diagnostics (Chaska, MN)
- …continuity risks.Collaborate with cross-functional teams across R&D, Procurement, Operations, Quality, and Regulatory Affairs to embed quality into all phases of ... plus if you also possess:Experience working in FDA-regulated industries or medical device manufacturing environments.Professional certifications such as CQE,… more
- Meta (Burlingame, CA)
- …the combination of AI with great form factors can do. We are seeking an experienced medical devices regulatory affairs professional to help us execute ... products with distribution into many worldwide markets. **Required Skills:** Medical Devices Regulatory Affairs...Medical Device Directive & European Union Medical Device Regulation, FDA regulatory … more
- System One (Malvern, PA)
- …in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. + Strong ... Job Title: Director of Regulatory and Medical Affairs ...and global regulatory requirements for class II medical devices including but not limited to… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jul 10, 2025 Location: Exton, Pennsylvania, US Department: ... regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and… more
- Medtronic (Irvine, CA)
- …relevant experience + Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs **This is not a remote position** ... **Nice To Have** + 4 years of experience in medical device regulatory affairs + Excellent technical knowledge of medical products and understanding… more
- Abbott (Plymouth, MN)
- …**Qualifications** + Minimum of 5 years' experience working with Class II and/or Class III medical devices . Regulatory Affairs Certification (RAC) is a ... their lives. **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Electrophysiology... regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices . +… more
- GE HealthCare (Madison, WI)
- …by the Regulatory Affairs Professionals Society (RAPS). + Experience in medical device regulatory affairs + Demonstrated life-long learner; ... pulse oximetry. You will work within a team of Regulatory Affairs professionals to ensure GE HealthCare...labeling compliance, etc. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is… more
- Cardinal Health (Boston, MA)
- …**_Qualifications_** + Bachelors in related field, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**...Brand, Presource, and Sustainable Technologies businesses and range of medical devices . + Maintain regulatory … more
- Stryker (Weston, FL)
- …3+ years of experience in an FDA regulated industry + 2+ years of experience in medical device regulatory affairs + Thorough understanding of FDA, ... Europe, and international medical device regulations + Experience drafting regulatory submissions... Affairs ) + Previous experience with Class II/III medical devices + Previous experience drafting 510(k)s… more
