- degree or above in a relevant discipline required
- years of industrial experience in IVD or medical device FDA registration
- in Chinese preferred
- 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
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Sr Manager Regulatory Affairs
4 weeks ago
Ocular Therapeutix Bedford, United StatesOcular Therapeutix, Inc. · Please ensure you read the below overview and requirements for this employment opportunity completely. · (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases a ...
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Sr Manager Regulatory Affairs
3 weeks ago
Ocular Therapeutix Bedford, United StatesOcular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYXTM. ...
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Manager, Regulatory Affairs
1 day ago
Takeda Pharmaceutical Company Ltd Lexington, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
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Manager, Regulatory Affairs
1 week ago
Deciphera Pharmaceuticals Waltham, United StatesCompany 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 ...
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Manager, Regulatory Affairs
3 weeks ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · Job DescriptionCompany 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 inhib ...
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Takeda Development Center Americas, Inc San Francisco, United States PermanentTakeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory · Affairs CMC Submissions · Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Scienc ...
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Government Affairs Manager
1 day ago
Global Partners Waltham, United StatesWe're hiring for a Government Affairs Manager who will be responsible for implementing strategies to advance the company's legislative and political agenda. Candidates should have a demonstrated ability to build trusted, direct relationships with key officials and policy staff. T ...
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Manager, External Affairs
4 days ago
Commonwealth of Massachusetts Boston, United States Full timeDescription · The Executive Office of Labor and Workforce Development (EOLWD) is looking for a creative, organized, and collaborative individual to join the team as Manager of External Affairs. Reporting to the Director of Communications and working closely with the Chief of Sta ...
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Student Affairs Events and Student Life Manager
2 weeks ago
Harvard University Boston, United States**Position Description** · - The Offices of Student Affairs (OSA), working with Program in Medical Education (PME) leadership, promotes the individual and professional growth and development of Harvard medical students. OSA includes the Offices of the Dean for Students, Recruitme ...
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Harvard University Boston, United States**Position Description** · - The Offices of Student Affairs (OSA), working with Program in Medical Education (PME) leadership, promotes the individual and professional growth and development of Harvard medical students. OSA includes the Offices of the Dean for Students, Recruitme ...
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Regulatory Affairs Manager
2 weeks ago
Katalyst HealthCares & Life Sciences Cambridge, United StatesResponsibilities: However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements ...
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Manager, Regulatory Affairs
2 weeks ago
ICAD, Inc Nashua, United StatesJob Description · Job DescriptionAbout iCAD: · iCAD, a global leader on a mission to create a world where cancer can't hide by providing clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outc ...
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Manager Regulatory Affairs
2 weeks ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · The Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Manager of Regulatory Affairs will support the regulatory lead on program related projects and be responsible for interacti ...
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Director/Senior Manager, Medical Affairs
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ConvaTec Lexington, MA, United StatesPioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infu ...
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Manager, Regulatory Affairs
2 weeks ago
Deciphera Pharmaceuticals Waltham, United StatesDeciphera 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 d ...
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Takeda Development Center Americas, Inc Lexington, United StatesTakeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory · Affairs CMC Submissions · Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Scienc ...
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Manager, Regulatory Affairs
1 week ago
Viridian Therapeutics Waltham, United StatesAt Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data- driven ...
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Manager, Regulatory Affairs CMC
2 weeks ago
Takeda Development Center Americas, Inc Cambridge, United StatesTakeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...
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Senior Manager, Regulatory Affairs
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Editas Medicine Cambridge, United States PermanentAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...
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Manager, Regulatory Affairs CMC
5 days ago
Takeda Development Center Americas, Inc San Francisco, United States PermanentTakeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...
Regulatory Affairs Manager - Bedford, United States - Genabio Diagnostics
3 weeks ago
Description
Qualifications:
Tasks: