- Tecomet (Woburn, MA)
- **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports ... To:** Senior Director of Quality Assurance and Regulatory Affairs **Date:** XX...create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …documents for SRC and IRB review and approval + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares,… more
- 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 ... reviewed with the RA management. + Driving improvement in regulatory aspects of the Quality Management System...if:** + You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical… more
- Cole-Parmer (Franklin, MA)
- Job Title: Sr. Manager, Quality and Regulatory Assurance Reports To: VP, Quality Position Location: Franklin, MA FLSA Status (Exempt/Non-Exempt): FLSA ... Status: Exempt Position Summary: The Senior Manager, Quality and Regulatory Assurance position is responsible...IVDD and IVDR compliance and regulations\ + Experience with FDA 21 CFR Part 820 regulations + Minimum of… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… more
- Sumitomo Pharma (Boston, MA)
- …other tools used within the group. + Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… 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
- Regeneron Pharmaceuticals (Cambridge, MA)
- …Director might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for investigational and ... management. + Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for...investigational and commercial products + Directs and oversees the Regulatory CMC function in preparing high- quality CMC… more
- Fresenius Medical Center (Waltham, MA)
- …high- quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global ... commercialization of pharmaceutical products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory… more
- United Therapeutics (Boston, MA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more