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Oxenham Group
Watertown, MA, United States
QUALIFICATIONS: - BS or MS in a scientific discipline with 7-10 years of direct experience in Quality Assurance and Regulatory Affairs within the Medical Device industry - Strong knowledge of FDA and global regulatory requirements (EU/UK Regulations, ICH Guidelines, Common Rule, 21 CFR 56, 45 CFR 46; ISO 13485, 21 CFR 820, 21 CFR Part 10, 21 CFR Pa
Job Source: Oxenham GroupFoundation 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 MedicineBioTalent 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 LtdCatalyst 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 SciencesDeciphera 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, IncDeciphera 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: BioTalentHiring 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!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 organization's goals.
This role will offer you
Lead an existing team across three sites while adding headcount.
Work on cutting edge technology found globally.
Industry leading benefit packages.
You will be responsible for
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.
Ensure regulatory compliance throughout the product lifecycle, including post-market surveillance.
You will bring the following
Minimum 5-7 years of IVD regulatory compliance submissions experience supporting Class I and Class II medical devices.
Experience with EU IVD Regulation/Directive and quality system standards.
Strong organizational, written and verbal communication skills
Email Alert for Regulatory Affairs Manager jobs in Norwood, MA, United States
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