- Parexel (Boston, MA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) - Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … more
- Sanofi Group (Cambridge, MA)
- **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 (Cambridge, MA)
- …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
- Sanofi Group (Cambridge, MA)
- …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
- Sanofi Group (Cambridge, MA)
- …Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global Research and ... Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800... global healthcare industry. + Proven experience in drug/ device combination product regulatory approvals. + Demonstrate… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA...a minimum of 1 year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical/medical device /biotech… more
- Danaher Corporation (Boston, MA)
- …position reports to the Director, Regulatory Affairs and is part of the Global Regulatory Affairs and will be fully remote. In this role, you will ... clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global ...and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device … more
- J&J Family of Companies (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... We are searching for the best talent for a ** Regulatory Affairs Specialist II** to support our...Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are **required** .… more
- Parexel (Boston, MA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … more
- Sanofi Group (Cambridge, MA)
- …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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...unmet needs. Sanofi is recruiting a new Director in Global Medical Affairs (GMA) based in Cambridge,… more
- Eliassen Group (Boston, MA)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager, Med Device , R&D PMO, Design Changes** **Anywhere** **Type:** Contract...modifications and component exchange programs while navigating a complex, global matrix organization. The project has completed feasibility and… more
- Avania (Boston, MA)
- …- Regulatory & Market Access Interns x2 We are seeking two, part-time Medical Device Regulatory Affairs & Quality Interns to join the Advisory team for ... outreach efforts. + Content Development + Contribute to creation of medical device regulatory and quality-focused white papers, blogs, and marketing materials.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/ Device , and Global Regulatory Affairs . + Advanced knowledge of ... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be...Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary… more
- Edwards Lifesciences (Boston, MA)
- …Familiarity with FDA PMA applications. + Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- Medtronic (Newton, MA)
- …workflow and product knowledge. + Collaborate with cross-functional teams, including R&D, regulatory affairs , and clinical teams, to ensure alignment on quality ... improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly...a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or… more
- Medtronic (Boston, MA)
- …Collaborate cross-functionally with software development, systems engineering, quality assurance, and regulatory affairs teams to ensure seamless integration and ... practices, test automation strategies, and emerging technologies relevant to medical device software. + Champion and implement Lean-Scaled Agile Framework (SAFe)… more
- Sanofi Group (Cambridge, MA)
- …an impact on millions around the world. In this role you will act as a global leader and expert on Data Privacy, promote and shape a culture of privacy, mastering ... of Sanofi Privacy Leadership and US Compliance Leadership team We are an innovative global healthcare company with one purpose: to chase the miracles of science to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …products within the US Market. You will report to the Head Counsel, Takeda Global Oncology, and you will work very closely with your Oncology Business Unit Clients. ... payers, pharmacy benefit managers (PBMs), Oncology GPOs, the Department of Veterans Affairs (VA), Federal Supply Schedule (FSS), Medicaid, the Department of Defense… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Co-leads CMC teams with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor ... risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product /… more
