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PSG 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 SolutionsFoundation 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!Deciphera 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 TherapeuticsDeciphera 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 PharmaceuticalsBioTalent
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: BioTalentDeciphera Pharmaceuticals, Inc
Waltham, MA, United States
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. Enabled by our propr
Job Source: Deciphera Pharmaceuticals, IncNorwood, 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. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organization's goals.
Essential Functions:
Lead the Regulatory Affairs team, including hiring, training, and performance evaluation.
Develop and implement regulatory strategies to ensure timely approvals of new and existing products.
Manage and maintain product registrations, licenses, and regulatory compliance globally.
Serve as the primary contact with regulatory agencies, including the US FDA, Notified Bodies, and other international entities.
Oversee the preparation of regulatory submissions, ensuring accuracy and compliance with all regulatory requirements.
Facilitate communication between regulatory authorities and company representatives.
Ensure regulatory compliance throughout the product lifecycle, including post-market surveillance.
Collaborate with the Quality Assurance team to support quality system processes and audits.
Promote a culture of continuous improvement and compliance within the organization.
Experience Requirements:
Minimum 5-7 years of IVD regulatory compliance submissions experience supporting Class I and Class II (IVDR Class A/B/C) medical devices.
Experience with EU IVD Regulation/Directive and quality system standards.
Strong organizational, written and verbal communication skills.
Education Requirements:
Bachelor’s degree in Science or Engineering. Advanced degree in Quality/Regulatory a plus.
Physical Requirements and Working Conditions:
Typical office environment.
Hybrid position with 3 days per week on site (typically Tuesday through Thursday).
Must be able to use basic office equipment: computer, printer, copier, telephone, etc.
Must be able to remain stationary for long periods of time.
Must be capable of communicating with stakeholders through various means.
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Email Alert for Regulatory Affairs Manager jobs in Norwood, MA, United States
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