Regulatory Affairs Manager
3 weeks ago
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
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Principal Regulatory Affairs Specialist
2 weeks ago
Bedford, United States Werfen Full timeOverview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture...
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Principal Regulatory Affairs Specialist
2 weeks ago
Bedford, United States Werfenlife SA. Full timeBedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States Country United States Shift 1st About the Position Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity,...
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Principal Regulatory Affairs Specialist
3 days ago
Bedford, United States Werfenlife SA. Full timeBedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States Country United States Shift 1st About the Position Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity,...
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Executive Director Regulatory Affairs Strategy
2 weeks ago
Bedford, United States Ocular Therapeutix Full timeSummary/Scope: A multifaceted Regulatory Affairs Team Leader role. Will be a key member of regulatory leadership to ensure the development, implementation and alignment of US/ ex US regulatory strategy across projects within Retina / Ophthalmology. Will represent the regulatory affairs function as a Core Member of Project Teams and be responsible for...
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Bedford, United States Ocular Therapeutix Full timeSummary/Scope: A multifaceted Regulatory Affairs Team Leader role. Will be a key member of regulatory leadership to ensure the development, implementation and alignment of US/ ex US regulatory strategy across projects within Retina / Ophthalmology. Will represent the regulatory affairs function as a Core Member of Project Teams and be responsible for...
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Executive Director Regulatory Affairs Strategy
2 weeks ago
Bedford, United States Ocular Therapeutix Full timeSummary/Scope: A multifaceted Regulatory Affairs Team Leader role. Will be a key member of regulatory leadership to ensure the development, implementation and alignment of US/ ex US regulatory strategy across projects within Retina / Ophthalmology. Will represent the regulatory affairs function as a Core Member of Project Teams and be responsible for...
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Regulatory Affairs Manager
10 hours ago
Bedford, United States Genabio Diagnostics Inc. Full time**Qualifications**: - Bachelor's degree or above in a relevant discipline required - 5+ years of industrial experience in IVD or medical device FDA registration - Proficiency in Chinese preferred **Tasks**: - Lead and support new product 510k Submissions - Lead and support International Device Licensing and Registrations - Support product development...
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Manager, Regulatory Affairs
2 days ago
Bedford, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
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Regulatory Affairs Specialist
24 hours ago
Bedford, United States Actalent Full time**Language fluency required: English & Chinese essential** Position Summary: The Regulatory Specialist will be responsible for China NMPA and Japan PMDA registration and renewal activities. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications,...
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Director, Regulatory Affairs
3 weeks ago
Bedford, United States Lantheus Full timeDescription Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that...
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Director, Regulatory Affairs
3 weeks ago
Bedford, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
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Director, Regulatory Affairs
2 weeks ago
Bedford, United States Lantheus Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
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Director, Regulatory Affairs
3 days ago
Bedford, United States Lantheus Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
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Director, Regulatory Affairs
2 days ago
Bedford, United States Lantheus Medical Imaging Inc Full timeJob DescriptionJob DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing...
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Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, United States Werfenlife SA. Full timeBedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States Country United States Shift About the Position Overview Werfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and...
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Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, United States Werfen Full timeOverview Werfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity...
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Senior Regulatory Affairs Specialist
1 month ago
Bedford, United States Werfen Full timeOverview: Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and...
-
Senior Regulatory Affairs Specialist
1 month ago
Bedford, United States Werfen Full timeOverview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture...
-
Senior Regulatory Affairs Specialist
2 days ago
Bedford, United States Werfen Full timeOverview: Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and...
-
Senior Regulatory Affairs Specialist
3 days ago
Bedford, United States Werfen Full timeOverview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture...