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Foundation 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 MedicineThe Judge Group
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: The Judge GroupDeciphera 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 PharmaceuticalsApogee 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 TherapeuticsGenabio Diagnostics
Bedford, MA, United States
Qualifications : degree or above in a relevant discipline required years of industrial experience in IVD or medical device FDA registration in Chinese preferred Tasks: and support new product 510k Submissions and support International Device Licensing and Registrations product development teams with new product submission requirements guidance on w
Job Source: Genabio DiagnosticsCatalyst Life Sciences
Canton, 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 tran
Job Source: Catalyst Life SciencesHiring 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 to the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representative on cross-fu
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: BioTalentCambridge, 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.
Develops detailed regulatory project plans and lead or support regulatory activities relating to specific portfolio of products/projects.
Participates as an active team member of the Global Regulatory Teams for assigned programs and provide strategic regulatory advice to project teams as required.
Coordinates responses to regulatory authorities questions with strict deadlines.
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Email Alert for Manager of Regulatory Affairs jobs in Cambridge, MA, United States
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