Regulatory Affairs Manager
4 days ago
Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD). Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the digital transformation of next gen devices.
This global role will see you shape and executing regulatory strategies for medical device software (SaMD) and IVD products (including AI). Instrumental to this rapidly growing function, you can see this as an opportunity to spearhead the regulatory function for a start up segment of a high growth multinational - providing the entrepreneurial environment of a start up, with the financial security of a multinational.
Requirements:
- Bachelor’s degree or higher in Science, Engineering, Regulatory Affairs, or a related field.
- Minimum of 5 years of experience in regulatory affairs, with at least 2 years focused on software as a medical device (SaMD) or IVD products.
- Advanced knowledge of global regulations, including FDA, MDR, IVDR, MDSAP, and relevant ISO standards (ISO 13485, ISO 14971, IEC 62304).
- Regulatory Expertise: Extensive knowledge of regulatory requirements for IVDs and SaMD across the product life cycle, including market approval, product changes, and post-market surveillance.
- Leadership & Influence: Ability to effectively communicate regulatory requirements to cross-functional teams, negotiate, and influence key stakeholders to ensure regulatory compliance.
- Quality Systems: Strong understanding of quality management systems (QMS), specifically as they relate to SaMD and IVD development and regulatory compliance.
-
Regulatory Affairs Manager
1 month ago
Boston, Massachusetts, United States Foundation Medicine Full timeAbout the JobThe Regulatory Affairs Manager is responsible for supporting the regulatory function and its activities, developing regulatory strategy, and contributing to the regulatory approval process for FMI products. FMI's products include diagnostic assays that provide molecular insights to physicians to guide treatment options for cancer patients.Key...
-
Regulatory Affairs Manager
3 days ago
boston, United States Spencer Rigby Full timeSpencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD). Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the...
-
Regulatory Affairs Manager
5 days ago
Boston, United States Takeda Pharmaceutical Full timeAbout the RoleTakeda is seeking a highly skilled Regulatory Affairs Manager to support the execution of regulatory CMC investigational, registration, and post-approval tasks for assigned products. As a key member of the Regulatory Affairs CMC team, you will work closely with cross-functional teams to develop project plans for global regulatory submissions...
-
Regulatory Affairs Director
2 weeks ago
Boston, Massachusetts, United States Spencer Rigby Full timeJoin Our Team as a Senior Manager Regulatory AffairsSpencer Rigby is a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes.We are seeking a highly skilled Senior Manager Regulatory Affairs Specialist to play a pivotal role in...
-
Regulatory Affairs Director
3 weeks ago
Boston, Massachusetts, United States Spencer Rigby Full timeJoin Our Team as a Senior Manager Regulatory AffairsSpencer Rigby is a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes.We are seeking a highly skilled Senior Manager Regulatory Affairs Specialist to play a pivotal role in...
-
Senior Manager Regulatory Affairs
3 weeks ago
Boston, United States Spencer Rigby Full timeSpencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes. As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.You will play a pivotal role in...
-
Senior Manager Regulatory Affairs
4 weeks ago
Boston, United States Spencer Rigby Full timeSpencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes. As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.You will play a pivotal role in...
-
Senior Manager Regulatory Affairs
4 weeks ago
Boston, United States Spencer Rigby Full timeSpencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes. As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.You will play a pivotal role in...
-
Senior Manager Regulatory Affairs
3 weeks ago
boston, United States Spencer Rigby Full timeSpencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD) that empower healthcare providers to deliver better patient outcomes. As a growing company, we are seeking a highly skilled Senior Manager Regulatory Affairs Specialist.You will play a pivotal role in...
-
Regulatory Affairs Expert
4 weeks ago
Boston, Massachusetts, United States Foundation Medicine Full timeRegulatory Affairs SpecialistThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process at Foundation Medicine. This involves developing regulatory strategies and submitting materials to health authorities such as the FDA for approval of novel platforms.Key Responsibilities:Develop and implement...
-
Regulatory Affairs Specialist
4 weeks ago
Boston, Massachusetts, United States Foundation Medicine Full timeSenior Specialist, Regulatory AffairsThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process at Foundation Medicine. This involves developing and implementing regulatory strategies to ensure compliance with health authority regulations, such as those set by the FDA. The successful candidate will be...
-
Regulatory Affairs Specialist
5 days ago
Boston, Massachusetts, United States Katalyst Healthcares and Life Sciences Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Katalyst Healthcares and Life Sciences. The successful candidate will be responsible for interpreting regulatory filings and leading cross-functional teams to ensure compliance with new or revised regulations.Key ResponsibilitiesInterpret regulatory filings and lead...
-
Regulatory Affairs Director
4 weeks ago
Boston, Massachusetts, United States ProClinical Full timeSenior Director, Regulatory Affairs **Job Summary:** Proclinical is seeking a seasoned regulatory professional to lead our vaccine development programs. As Senior Director, Regulatory Affairs, you will be responsible for driving regulatory efforts and ensuring compliance across major markets. **Key Responsibilities:** * Develop and execute regulatory...
-
Regulatory Affairs Specialist
2 weeks ago
Boston, Massachusetts, United States Katalyst Healthcares and Life Sciences Full timeRegulatory Affairs SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing regulatory guidance to cross-functional partners and developing global regulatory strategies for new and modified medical devices.Key...
-
Mgr, Regulatory Affairs
1 month ago
Boston, United States Foundation Medicine Full timeAbout 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. FMI’s products include diagnostic assays that provide molecular insights to...
-
Regulatory Affairs Specialist
1 month ago
Boston, Massachusetts, United States Katalyst Healthcares and Life Sciences Full timeRegulatory Affairs SpecialistKatalyst Healthcares and Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to join our team.Key Responsibilities:Provide regulatory guidance to cross-functional partners and develop global regulatory strategies for new and modified medical devices.Assist in the development of regulatory strategies for new...
-
Director, Regulatory Affairs
7 hours ago
Boston, United States Meet Full timeDirector of Regulatory Affairs (CRO)Remote Opportunity - Candidates must be based in CST or ESTMeet has partnered with a mid-sized CRO that is looking for a Director of Regulatory Affairs to join their team. This candidate will be overseeing all Regulatory Strategy projects for the organization across a wide variety of therapeutic areas and modalities. Key...
-
Regulatory Affairs Director
5 days ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeJob Title: Associate Director, Global Regulatory AffairsAt Takeda Pharmaceutical, we are seeking an experienced Associate Director, Global Regulatory Affairs to join our team in Cambridge, MA.Job Summary:We are looking for a highly skilled and motivated individual to lead our global regulatory strategy and ensure compliance with regulatory requirements. The...
-
Regulatory Affairs Manager
5 days ago
Boston, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the Role:Takeda Pharmaceutical is seeking a highly skilled Regulatory Affairs Manager to support the execution of regulatory CMC investigational, registration, and post-approval tasks for assigned products. As a key member of the Regulatory Affairs CMC team, you will work closely with cross-functional teams to develop project plans for global...
-
Regulatory Affairs Specialist
5 days ago
Boston, Massachusetts, United States Katalyst Healthcares and Life Sciences Full timeJob Title: Regulatory Affairs SpecialistAt Katalyst Healthcares and Life Sciences, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the compliance of our medical devices with global regulatory requirements.Responsibilities:Develop and implement...