- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the… more
- Sanofi Group (Cambridge, MA)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting ... pathways. The team is accountable for developing and implementing global regulatory strategies for device ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Oracle (Boston, MA)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration ... across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. **Responsibilities** **Preferred… more
- Oracle (Boston, MA)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing… 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 ... variations) around small molecule drug substance, drug products and drug- device combination products. Ensure compliance with global ...local and/or global functional units [OPC CMC Global Regulatory Affairs , Global… more
- GRAIL (Boston, MA)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For... device , or pharmaceutical industries is required. + Regulatory affairs and IVD device … more
- Takeda Pharmaceuticals (Boston, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products… 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 ... care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA....+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited… 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 ... background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10...deep expertise in developing and executing global regulatory strategies across drug and device development.… more
- Philips (Cambridge, MA)
- …+ You've acquired a minimum of 7+ years' experience in Regulatory Affairs /Strategy within FDA regulated Medical Device environments. + You have proven ... The Principal Regulatory Affairs Specialist will develop and...projects across a spectrum of product lines. + Monitor global regulatory landscapes and guide cross-functional teams… more
- Sanofi Group (Cambridge, MA)
- …other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically within advertising ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …councils, inspection support, and industry interactions. + Partner with critical stakeholders in Regulatory Affairs , Device Quality, and PharmSci to ensure ... Device Compliance leads and cross-functional stakeholders to drive alignment and uphold Takeda's global device quality standards. You will play a key role in… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/ Device , and Global Regulatory Affairs . + Advanced knowledge of ... interactions. + Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be...Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary… more
- Takeda Pharmaceuticals (Boston, MA)
- …with key functions across Takeda Oncology including Translational Medicine, Clinical Sciences, Global Regulatory Affairs , the Oncology Business Unit ... and clinical data integration. + Understanding of key considerations relevant to global regulatory requirements + Experience developing team culture, resolving… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners ... if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality… more
- Wolters Kluwer (Waltham, MA)
- …enabling engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA, EU MDR, ISO 13485, and IEC ... The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs , clinical, and quality assurance teams, facilitating strategic… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the US Compliance Committee. + Working collaboratively across functions, including Compliance, Regulatory and Medical Affairs , to support a policy, training and ... Oncology Business Unit. You will participate in US and global integrated brand teams, advising on FDA laws and...work very closely with your Oncology Commercial and Medical Affairs clients. As a member of the extended Takeda… more
- Medtronic (Boston, MA)
- …+ Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs , to define and implement systems engineering processes ... knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety,… more
- Medtronic (Newton, MA)
- …workflow and product knowledge. + Collaborate with cross-functional teams, including R&D, regulatory affairs , and clinical teams, to ensure alignment on quality ... improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly...a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or… more