- 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
- Sanofi Group (Bridgewater, NJ)
- …the job** The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for products in the Rare Disease, ... **Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About… 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 (Cambridge, MA)
- …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
- Novo Nordisk (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/ Lead Regulatory Scientist/Sr. Manager ... related experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory experience… 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
- IQVIA (Atlanta, GA)
- …to subject/patient recruitment and on time high quality data collection. The Clinical Lead provides leadership of the clinical team, in support of the project ... for Request for Proposals (RFPs). + Participate in bid defense preparations. Lead the Clinical delivery strategy at bid defense presentations in partnership with… 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
- 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
- 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)
- …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
- 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
- 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
- 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
- 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
- Abbott (Alameda, CA)
- …sensing technology. *This role is 100% onsite in Alameda As the Clinical Research Associate I you will ensure quality, accuracy, and integrity of clinical trial data ... (GCPs), ICH guidelines, Federal Regulations, department procedures, and other applicable regulatory requirements. + Participate in study start up activities. +… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** Under the leadership and directional guidance of the Associate Director, External Audits & Inspections Management Lead , who drives and ... and Quality Assurance including solid knowledge of global GXP Quality and regulatory requirements including medical device regulations. Proven excellent written… more