- Oracle (Boston, MA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Cardinal Health (Boston, MA)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- Sanofi Group (Cambridge, MA)
- …Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...without relying on authority, including participating in cross-functional groups ( medical , legal, regulatory , etc.) to lead toward… more
- GRAIL (Boston, MA)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals. + Effective… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across… more
- J&J Family of Companies (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... We are searching for the best talent for a ** Regulatory Affairs Specialist II** to support our...in a highly regulated industry **required** , preferably in medical device (1+ years with Advanced Degree).… more
- Dentsply Sirona (Waltham, MA)
- …Years and Type of Experience: + 5(+) years of experience in regulatory affairs , preferably in the medical device industry. + Experience with leading ... + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited...13485, EU MDR). + Experience with software as a medical device , AI and/or medical … more
- Evident Scientific (Needham, MA)
- … (US Focus)** + Act as US regulatory lead for clinical and medical device products, overseeing FDA submissions (510(k), PMA) and communications. + Ensure ... Sr. Mgr., Regulatory Affairs (RA) & Clinical ...Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs (Evident... Affairs and RA with focus on Clinical Affairs and Clinical Trial management for Medical … more
- Philips (Cambridge, MA)
- …if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs /Strategy within FDA regulated Medical Device environments. + You have ... The Principal Regulatory Affairs Specialist will develop and...The Principal Regulatory Affairs Specialist will develop and execute the ...corrections, with a primary focus on Software as a Medical Device (SaMD) for our Sleep &… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more