Regulatory Affairs Specialist II

Bedford - 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,...

Bedford - 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,...

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, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture...

Summary/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...

Summary/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...

Bedford - 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...

Summary/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...

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 independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity...

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, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and...

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, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture...

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, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture...

This role is HYBRID in Bedford, MA. Flexible days in office 3x/week. **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...

This role is HYBRID in Bedford, MA. Flexible days in office 3x/week. **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...

Description 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...

Job 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...

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 provides...

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 provides...

Job 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...

Qualifications:degree or above in a relevant discipline requiredyears of industrial experience in IVD or medical device FDA registrationin Chinese preferredTasks:and support new product 510k Submissionsand support International Device Licensing and Registrationsproduct development teams with new product submission requirementsguidance on worldwide regulatory...

Qualifications:degree or above in a relevant discipline requiredyears of industrial experience in IVD or medical device FDA registrationin Chinese preferredTasks:and support new product 510k Submissionsand support International Device Licensing and Registrationsproduct development teams with new product submission requirementsguidance on worldwide regulatory...