- 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
- 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 ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing… 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)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... 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 is required.… 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
- 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
- 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
- Bristol Myers Squibb (Cambridge, MA)
- …more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Advanced Degree (MS, Ph.D., etc.) required. + 10+ years of overall biopharmaceutical/ device industry experience with 8+ years pharmaceutical Regulatory CMC and ... as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as… more
- Fujifilm (Boston, MA)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Sanofi Group (Cambridge, MA)
- …strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...teams. + Contribute to and execute innovative and sustainable medical device regulatory strategies covering… more
- Takeda Pharmaceuticals (Lexington, MA)
- …councils, inspection support, and industry interactions. + Partner with critical stakeholders in Regulatory Affairs , Device Quality, and PharmSci to ensure ... medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …Massachusetts. This announcement is intended to fill multiple vacancies throughout the Veterans Affairs Medical Center in Bedford, MA. Available shifts could be ... is located in the Nursing Service (Mental Health) at the Bedford VA Healthcare Medical Center, in Bedford, Massachusetts. This is a full time position at 40-hours… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Philips (Cambridge, MA)
- …a master's degree or higher in areas such as Medical /Clinical Affairs / Medical Safety in the Medical Device industry strongly preferred. Prior bedside ... + Your skills include a strong of relevant standards and regulations for the medical device industry (ISO, IEC, etc.). You have strong knowledge and… more
- AbbVie (Cambridge, MA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director, Medical Affairs + Health Impact (MHI) is a key scientific ... industry recognized qualification eg MSc + 5-7+ years of prior biopharmaceutical/ medical device industry experience, including substantial understanding of… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more
- Wolters Kluwer (Waltham, MA)
- …a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… more
- Astrix Technology (Boston, MA)
- …Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide medical insights that inform strategic ... medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of therapeutic… more