- Sanofi Group (Cambridge, MA)
- **Job title: Device Regulatory Lead ( Associate Director)** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global ... thought was possible. Ready to get started? **Main responsibilities** + Serve as Device Regulatory Lead on assigned project teams (early phase, late stage… more
- Merck (Rahway, NJ)
- …current in relevant worldwide regulatory guidance and standards. + Lead /support/oversee clinical supplies production with respect to device component ... lead cross-functional development teams within and external to Device Development. The incumbent must be able to work... Working Group to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Insight Global (New Brunswick, NJ)
- Job Description Our large medical device client is looking for a Sr. RA Lead to join their team and assist with a backlog of projects. This individual will be ... helping the manufacturing site with necessary change assessments. They will draft regulatory changes and submissions for these class III products, notify world… more
- Stryker (Portage, MI)
- …More information is available at www.stryker.com . We are currently seeking an ** Associate ** **Manager, Regulatory Affairs** to join our **Acute Care business ... regulatory requirements at the local, state, or federal/ regulatory agency levels. + Lead teams to.... + A minimum of 3 years of Medical Device Quality or Regulatory Affairs experience required.… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …cytometer experience a plus. + Premarket Experience: Experience supporting medical device regulatory submissions; proven experience with application of quality ... manage the performance review, hiring and firing process for Regulatory Affairs professionals under his/her direction. + Lead...in an US FDA/or ISO regulated environment and medical device industry. + EU MDR/IVDR experience. + History of… more
- Sanofi Group (Bridgewater, NJ)
- …the job** The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs ... **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About… more
- Guidehouse (Mclean, VA)
- …undoubtedly a transformative time for regulators, developers, and patients. Guidehouse's Regulatory Life Sciences practice is an engine of innovation helping ... pharmaceutical, biotech, medical device , and diagnostic regulators tackle today's challenges, while anticipating...today. Are you up for the challenge? As an Associate Director within the Guidehouse Public Health practice, you… more
- Dr. Reddy's Laboratories (Middleburgh, NY)
- …traditional background. **Job Description** **Job Summary** We are looking for Manager / Lead Associate Quality Control to provide support to the Middleburgh ... options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready… more
- Teva Pharmaceuticals (West Chester, PA)
- …registration. This position comes with 4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director, Regulatory Affairs CMC is responsible for ... Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13,...associated with product development including product and process development, device development, analytical methods, formulation development, manufacturing, and labeling.… more
- Novo Nordisk (Princeton, NJ)
- …preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Associate Director will ... high level strategic input into development plans, study designs, and regulatory submissions. Relationships The Associate Director, Medical Writing (ADMW)… more
- Lilly (Concord, NC)
- …procedures, quality processes and controls for the Parenteral manufacturing area. + Lead area tours to support business reviews, regulatory audits, or ... North Carolina which will house warehousing & logistics, parenteral operations, medical device assembly, and packaging, QC laboratories, and support teams to produce… more
- Abbott (Atlanta, GA)
- …working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and ... products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier.… more
- AbbVie (North Chicago, IL)
- …and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. Lead DevSci cross-functional initiatives and strategies. From ... among ASDT/ALB and various line functions. Partners with Clinical, Regulatory , Operations, Quality, Pre-clinical Safety, and Commercial organizations. Apprises CMC… more
- Medtronic (Boston, MA)
- …Medical Education, Global Field Training, Clinical Research, Research and Development, Regulatory and Legal. **A DAY IN THE LIFE - POSITION RESPONSIBILITIES:** ... updated best practices within region + Develops therapy and device operational knowledge and applies this knowledge to processes...as the District Expert and function as the District Lead for simulation + Collaborates with the Global Field… more
- Lilly (Concord, NC)
- …of the Parenteral/ Device Assembly and Packaging areas as well as lead / assist in operations readiness programs (eg Material procurement and definition, training ... solutions to improve or meet key performance indicators (KPI) for the area. + Lead area tours to support business reviews, regulatory audits, or network… more
- Lilly (Concord, NC)
- …people around the world. **Responsibilities:** During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and ... up, and validation of the parenteral operations (PAR) OR device , assembly, and packaging (DAP) areas. Once the facility...is a perceived unsafe or product impacting situation. + Lead /conduct area deviation and corrective action discussions with a… more
- Teva Pharmaceuticals (Salt Lake City, UT)
- Associate Director Project Management Date: Jun 28, 2024 Location: Salt Lake City, United States, Utah, 84044 Company: Teva Pharmaceuticals Job Id: 56606 **Who we ... and new people to make a difference with. **The opportunity** The Associate Director, Project Management has overall responsibility and accountability for end-to-end… more
- Amgen (New Albany, OH)
- …best work alongside other innovative, driven professionals in this meaningful role. **Sr Associate Plant QA (12 hour 6pm-6am)** **Live** **What you will do** Let's ... Let's change the world. In this role as Senior Associate Plant QA, you will be working in a...team providing QA oversight to GMP operations in the Device Assembly and Finished Product Packaging Area. The Sr.… more
- Integra LifeSciences (Plainsboro, NJ)
- …help improve outcomes. The ** Lead Quality Inspector** serves as a Lead Associate , Quality Inspector for the Plainsboro Manufacturing Site, Collagen ... Manufacturing Center (CMC). The lead associate is responsible for performing and/or...policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory … more
- AbbVie (North Chicago, IL)
- …requirements for new digital endpoints, critical success factors and obstacles impacting device driven outcomes in successful regulatory label negotiations + ... Science Team is a novel capability team bridging medical, scientific, technology, regulatory , and data science expertise to deploy digital health technologies (DHTs)… more