Regulatory Affairs Manager

About 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...

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...

About 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...

Join 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...

Join 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...

Spencer 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...

Spencer 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...

Spencer 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...

Spencer 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 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...

Senior 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...

Job 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...

Senior 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 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...

About 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 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 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...

Job 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...

About 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...

Job 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...