- Merck & Co. (Rahway, NJ)
- 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
- 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
- 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
- Abbott (Atlanta, GA)
- …enterprise/cross-division business unit model. Experience working in the Medical Device industry. Regulatory Affairs Professionals Society Certification ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Cleerly (Denver, CO)
- …as a medical device (SAMD) Minimum 7 years of medical device experience in a regulatory affairs role. Experience in global regulatory ... regulatory submission pathways and approval options. Global Regulatory Compliance: Ensure medical devices ...changes, particularly for AI/ML standards and Software as a Medical Device (SaMD) regulations. Regulatory … 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
- Experis (St. Paul, MN)
- …to participate in a global healthcare spin-off. Be a key contributor to regulatory affairs for medical devices and drug products. Work in a collaborative ... Our client, a global leader in medical device manufacturing , is seeking a Regulatory Affairs Specialist to join their team, fully remote , reporting to… 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
- Leica Biosystems (Miami, FL)
- …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 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
- Abbott (San Diego, CA)
- …Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic decision-making ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Minneapolis, MN)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... and get on with their lives. The Opportunity The Regulatory Affairs Manager will work on-site at...Prior experience supervising and coaching a team. Experience with Medical Devices . Must be able to juggle… more
- Abbott (Alameda, CA)
- …in technical area or MBA Minimum 5+ years' experience in regulatory affairs . Experience working with Medical Devices , software, or combination products. ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Atrium Medical (Hudson, NH)
- …internal, domestic, and international compliance activities working under the direction of the Regulatory Affairs Director. Assists the Regulatory Affairs ... the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other International regulations. Participates… more
- Bausch Health (Bridgewater, NJ)
- Associate Director, Regulatory Affairs Job Location: Hartford, Connecticut, USA | NewHaven, Connecticut, USA | Stamford, Connecticut, USA | Atlanta, Georgia, USA ... and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/… more
- Nesco Resource (Dublin, OH)
- …*Must be familiar with and comfortable using computers. *Working knowledge of the medical device regulatory procedures, lean manufacturing, and manufacturing ... The Assembler I position will inspect, weigh, package, and sort out defective medical devices as required. Essential Duties & Responsibilities *Keep work area… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Trained Board Certification. Minimum of 10-12 years of biotechnology/pharmaceutical/ medical device industry experience in medical affairs , medical ... about Life at Olympus. Job Description The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a...with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training,… more
- Katalyst HealthCares and Life Sciences (Chula Vista, CA)
- …in regulatory body audits. Requirements: Bachelor's degree in science, Engineering, Regulatory Affairs , or other technically related fields. 8-10+ years of ... experience with Class II and/or III medical devices , including EU MDR/MDD experience. ...EU, and other key market submissions. Experience with international medical device regulations, standards, and guidance documents… more
- Johnson and Johnson (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Affairs ... Job Description: Johnson and Johnson is currently seeking a Medical Director, Medical Affairs , Orthopedics...cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics… more
