- 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
- Evident Scientific (Needham, MA)
- …operations, supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, ... across global and regional projects. **Key Responsibilities** ** Regulatory Affairs (US Focus)** + Act as... Affairs (US Focus)** + Act as US regulatory lead for clinical and medical device … more
- Medtronic (Mansfield, MA)
- …Have: Minimum Requirements** + Bachelors degree with 4+ years of regulatory affairs experience in the medical device , biotech or pharmaceutical industry OR a ... to technical documents to support CE marking and other global product registrations as necessary + Interact and negotiate...Masters degree with 2+ years of regulatory affairs experience in the medical device , biotech… 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
- Parexel (Boston, MA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … 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
- 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
- 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
- Bausch + Lomb (Boston, MA)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work...Affairs . This position does not work with medical device , cosmetics or supplements and we will only be… more
- ThermoFisher Scientific (Waltham, MA)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... Day in the Life:** + Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...unmet needs. Sanofi is recruiting a new Director in Global Medical Affairs (GMA) based in Cambridge,… 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
- IQVIA (Boston, MA)
- **Manager, Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... of innovative medical treatments. Our diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies… more
- Takeda Pharmaceuticals (Lexington, MA)
- …device development teams + Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial ... and Device Development (DPDD) group provides strategic clinical leadership for global device and combination product development programs. This pivotal role… more
- Avania (Boston, MA)
- …- Regulatory & Market Access Interns x2 We are seeking two, part-time Medical Device Regulatory Affairs & Quality Interns to join the Advisory team for ... outreach efforts. + Content Development + Contribute to creation of medical device regulatory and quality-focused white papers, blogs, and marketing materials.… more
- Pfizer (Cambridge, MA)
- **JOB SUMMARY** Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global ... within the assigned portfolio, and other disease areas as relevant including ensuring global regulatory strategies for all projects and products within the… 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