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Apogee Therapeutics
Boston, MA, United States
Role Summary We are seeking a Manager, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. Reporting to the Executive Director of Regulatory Affairs, you will have the opportunity to oversee the imp
Job Source: Apogee TherapeuticsPSG Global Solutions
Cambridge, MA, United States
Description We're looking for a Manager of Regulatory Affairs , working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States . Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Develop
Job Source: PSG Global SolutionsDeciphera Pharmaceuticals
Watertown, MA, United States
Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Job Source: Deciphera PharmaceuticalsFoundation Medicine
Boston, MA, United States
About the Job The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representative on cross-func
Job Source: Foundation MedicineHiring Now!
Boston, MA, United States
About the Job The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representative on cross-funct
Job Source: Hiring Now!BioTalent
Norwood, MA, United States
Introduction BioTalent is representing a top-tier life sciences device manufacturer hiring a Regulatory Affairs Manager ensure compliance with global regulatory requirements while managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organiz
Job Source: BioTalentBioTalent Ltd
Norwood, MA, United States
Summary: The Regulatory Affairs Manager is responsible for overseeing all regulatory activities within Advanced Instruments. This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. T
Job Source: BioTalent LtdFoundation Medicine
Boston, MA, United States
Job Description About the Job The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representat
Job Source: Foundation MedicineCanton, MA, United States
Opportunity to join a global medical instrumentation organization as they grow the regulatory team due to successful acquisitions and increases to their product portfolio. Focusing on existing products, you'll have global reach on ensuring they remain compliant with US, EU IVDR, and global regulations.
Responsibilities:
Lead and coordinate the transition of the IVD products from current regulations to IVDR requirements.
Interpret and apply IVDR guidelines to ensure product compliance as an individual contributor.
Develop regulatory strategies and provide guidance on IVDR implementation to project teams.
Experience Required
Bachelor's degree in a scientific or technical discipline; advanced degree preferred.
Minimum 4 years of experience in regulatory affairs within the medical device industry, with specific expertise in IVDs and knowledge of IVDR.
Proven experience in preparing and submitting regulatory filings (e.g., CE Marking, FDA submissions).
Strong understanding of IVDR requirements and their application to IVD products.
Email Alert for Regulatory Affairs Manager jobs in Canton, MA, United States
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