Regulatory Affairs Manager

Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and signific Regulatory Affairs, Specialist, Regulatory, International, Registration, Manufacturing, Business Services

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...

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**: - 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...

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...

Job DescriptionJob DescriptionThe Vice President, Medical Affairs will lead the Medical Affairs function including Medical Science Liaisons, Clinical Science Liaisons, Medical Affairs Operations, Global Medical Information, Clinical Science Communications, and Investigator Sponsored Trials for all therapeutic indications for all marketed products, products...

Job DescriptionJob DescriptionThe Vice President, Medical Affairs will lead the Medical Affairs function including Medical Science Liaisons, Clinical Science Liaisons, Medical Affairs Operations, Global Medical Information, Clinical Science Communications, and Investigator Sponsored Trials for all therapeutic indications for all marketed products, products...

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...

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...

Overview: Find out for yourself why Southcoast Health has been voted ‘Best Place to Work’ for 6 years in a row!    Join Southcoast Health, where your future is as promising as the care we provide. Our commitment to each other, our patients, and our community is more than a mission - it’s our way of life, and you’ll be at the heart of...

Job Title: SeniorSoftware Engineer Location: Bedford, Massachusetts Company Overview: [Company Name] is a leading medical device company dedicated to advancing healthcare through innovative technologies. Our mission is to improve patient outcomes by developing cutting-edge medical devices that enhance diagnostic accuracy, streamline workflows, and empower...

Job DescriptionJob DescriptionMAINSAIL Group is in search of  Senior Program Managers for opportunities located at Hanscom AFB, in Bedford, Massachusetts. The Program Manager's primary function will be to provide comprehensive knowledge of principles, policies, and practices of systems acquisition and program management.Responsibilities include:The...

Job Title: Senior Software Engineer Location: Bedford, Massachusetts Company Overview: [Company Name] is a leading medical device company dedicated to advancing healthcare through innovative technologies. Our mission is to improve patient outcomes by developing cutting-edge medical devices that enhance diagnostic accuracy, streamline workflows, and empower...

Responsibilities : Design, develop, and optimize processes for the manufacturing of medical devices, such as injection molding, extrusion, assembly, packaging, sterilization, etc. Conduct process characterization, design of experiments (DOE), risk assessment, and statistical analysis to identify and control critical process parameters and sources of...

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 have helped physicians enhance patient care with our broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that...

The CompanyDelix Therapeutics is a neuroscience company focused on harnessing the power of psychoplastogens—novel neuroplasticity-promoting therapeutics—to treat brain health disorders. Delix is advancing these compounds through preclinical and clinical development to bring patients FDA-approved medicines that will address significant unmet needs....

The CompanyDelix Therapeutics is a neuroscience company focused on harnessing the power of psychoplastogens—novel neuroplasticity-promoting therapeutics—to treat brain health disorders. Delix is advancing these compounds through preclinical and clinical development to bring patients FDA-approved medicines that will address significant unmet needs....