- Philips (Cambridge, MA)
- …new product development projects, ensuring our state-of-the-art Ultrasound Products meet FDA , and other governmental agency/notified body Regulatory Compliance ... if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical...stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of… more
- Philips (Cambridge, MA)
- …on time. + Your skills include extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical ... **Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)** The...proactive, strategic relationships with external stakeholders (notified Bodies, US FDA , Competent Authorities, etc.) to ensure that requirements are… more
- Sumitomo Pharma (Boston, MA)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- Sumitomo Pharma (Boston, MA)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …(eg, clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Rhythm Pharmaceuticals (Boston, MA)
- …for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage ... to overcome barriers, together. Opportunity Overview The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory … more
- Grifols Shared Services North America, Inc (Worcester, MA)
- Would you like to join an international team working to improve the future of healthcare ? Do you want to enhance the lives of millions of people? Grifols is a global ... healthcare company that since 1909 has been working to...110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development,… more
- Sanofi Group (Cambridge, MA)
- …on organizational structure. **About You** **COMPETENCES** + Strong knowledge of global regulatory labeling requirements ( FDA , EMA, ICH) and lifecycle labeling ... **Job Title:** Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...labeling development and negotiation. We are an innovative global healthcare company with one purpose: to chase the miracles… more
- Nanobiosym, Inc. (Cambridge, MA)
- …federal, state, and international tax regulations while managing government contracts and healthcare -related regulatory requirements (eg, FDA , IRB approvals, ... 10+ years of legal experience (in-house and law firm), with expertise in healthcare , regulatory compliance, corporate governance, and IPO preparation. + Strong… more
- Rhythm Pharmaceuticals (Boston, MA)
- …for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage ... to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development… more
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