- Sanofi Group (Cambridge, MA)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to shape the ... In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and… more
- ThermoFisher Scientific (Boston, MA)
- …full-time benefits. **Key responsibilities:** + Support preparation of global regulatory submission sections, for late-stage and commercial programs in analytical ... Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization. + Collaborate cross-functionally with… more
- Dana-Farber Cancer Institute (Boston, MA)
- …donor status including progress, challenges, and adjustments. + Ensure compliance with all regulatory bodies (eg, FDA , AABB, FACT, NMDP) related to donor ... logistical, and administrative aspects of donor services, ensuring compliance with regulatory standards and supporting overall operations of the Cellular Therapy… more
- Hologic (Marlborough, MA)
- …research or R&D. + Expertise in clinical study design, evidence generation, and regulatory compliance (eg, FDA , ISO, GCP). + Strong knowledge of biostatistics ... working cross-functionally to generate high-quality clinical evidence that supports regulatory clearance, market adoption, and business growth. **Key Responsibilities:**… 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 for the implementation and...IVDD and IVDR compliance and regulations\ + Experience with FDA 21 CFR Part 820 regulations + Minimum of… more
- Cytel (Cambridge, MA)
- …with Bayesian methods preferred. + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want ... complex manufacturing data to ensure product quality, consistency, and regulatory compliance. **As a Principal Biostatistician, your responsibilities will include:**… more
- Nanobiosym, Inc. (Cambridge, MA)
- …and international tax regulations while managing government contracts and healthcare-related regulatory requirements (eg, FDA , IRB approvals, and liability ... environment and is ready to tackle a wide range of legal, regulatory , and compliance challenges. The ideal candidate is a skilled negotiator, exceptional… more
- Medtronic (Boston, MA)
- …business cases and associated KPIs + Experience working under regulations of the FDA , notified bodies, and other regulatory agencies for successful commercial ... you'll lead dynamic teams, collaborating across departments like Strategy, Marketing, Quality, Regulatory and R&D to protect and grow market share while accelerating… more
- Medtronic (Boston, MA)
- …like Prochain and Resource First + Experience working under regulations of the FDA , notified bodies, and other regulatory agencies for successful commercial ... balancing time, schedule, cost, and quality, while adhering to safety and regulatory standards. + Manage project financials, including forecasting and tracking of… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part of Regeneron… more