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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 MedicineDeciphera 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 PharmaceuticalsHiring 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 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 MedicinePSG 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 SolutionsBedford, 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 worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed
and support the implementation of clinical research projects
and support clinical sites management through all phases of the clinical trial
to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled
that documentation from clinical trial sites meets FDA/GCP/GDP requirements
Email Alert for Regulatory Affairs Manager jobs in Bedford, MA, United States
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