- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the… more
- Sanofi Group (Morristown, NJ)
- …turn the impossible into possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a ... **Job Title:** Head of Global Regulatory Affairs , CMC...Device teams to achieve the implementation of appropriate global regulatory strategies. Assures that, for major… more
- Sanofi Group (Morristown, NJ)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting ... pathways. The team is accountable for developing and implementing global regulatory strategies for device ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Stryker (Mahwah, NJ)
- …launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time zones ... **Senior Manager, Regulatory Affairs - Joint Replacement Division**...provide leadership and coordination of the Joint Replacement divisions' global regulatory strategies, submission preparation and approvals… more
- Pentax Medical (Montvale, NJ)
- …devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... for Endoscopes and Speech, Voice and Swallowing devices, meet global regulatory standards. This role will collaborate...shaping the future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …or a related field **Experience** + Minimum of 5 years of experience in regulatory affairs within the medical device industry **Knowledge and Skills** ... a **maker of possible** with us. **Job Overview** Working closely with the Director of Regulatory Affairs , the Regulatory Affairs Manager - RA Strategy… more
- Sanofi Group (Morristown, NJ)
- …other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically within advertising ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …the core team, aiding product development, remediation projects, and meeting medical device regulatory needs. + Review, comprehend, and compose performance and ... role in crafting the future of medical technology and making a tangible impact on global health. **Responsibilities:** + Present the medical affairs role within… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …possible** with us. **Job Summary:** The Strategy Manager will support the MDS Global Medical Affairs Strategy by performing tactical initiatives in early ... continuous clinical education. + Contributes to cross-functional partnerships between Medical Affairs , Commercial, Regulatory and R&D, and supports the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device regulations and lead the development ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent...change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions… more
- Wolters Kluwer (New York, NY)
- …enabling engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA, EU MDR, ISO 13485, and IEC ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Tanabe Pharma Group, including… more
- Danaher Corporation (New York, NY)
- …collaborating with cross-functional teams including Product Management, Legal, IP, Finance, R&D, Regulatory Affairs , Clinical Affairs , Sales & Marketing, ... of people worldwide - and we're using our unmatched global scale and proven playbook to make it happen,...to execute with supporting organizations (sales, commercial marketing, medical affairs , R&D, manufacturing, regulatory , quality, etc.) on… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …+ Collaborate closely with product management, hardware engineering, quality assurance, and regulatory affairs teams to ensure alignment and successful product ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...Proven experience managing software development teams in the medical device industry, with a strong understanding of regulatory… more
- Adecco US, Inc. (Morristown, NJ)
- …organizational templates. + Collaborate with cross-functional teams including Quality, Manufacturing, Global Regulatory Affairs , and Contract Manufacturing ... variations, and annual reports. + Prepare and evaluate change controls for global regulatory impact; occasionally author technical reports, position papers,… more
- Danaher Corporation (New York, NY)
- …regulatory , market access, and post-market). You'll collaborate with clinical, regulatory /quality, R&D, medical affairs , IT/security, and our Operating ... of people worldwide - and we're using our unmatched global scale and proven playbook to make it happen,...tools. + Proven experience analyzing RWE/RWD (EHR, claims, registries, device logs) for clinical, regulatory , or market… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Ensure program success by working cross functionally with R&D-Engineering, Marketing, Medical Affairs , Manufacturing, Quality and Regulatory Affairs . + ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...science and engineering principles + Working experience in medical device industry + Familiar with design control process and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …risk assessments, method development, and validation activities, supporting compliance with global regulatory requirements and internal quality standards. The ... requires strong collaboration with cross-functional teams, including Platform Product R&D, Regulatory Affairs , and Manufacturing, to deliver safe, effective, and… more
- Danaher Corporation (New York, NY)
- …Managers towards it; build and maintain strong relationships with R&D, Clinical & Regulatory Affairs , Marketing, Operations, and Quality + Own & improve Beckman ... roadmap that drives new product development, product lifecycle management, and global product registration expansion & protection + Partner with product management… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. Tanabe Pharma Corporation has discovered and produced several ... in 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain, and business development functions. TPA is dedicated to… more