- Dana-Farber Cancer Institute (Brookline, MA)
- …regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with DFCI and DF/HCC policies as well as federal regulation and ... interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions.… more
- Hologic (Marlborough, MA)
- Director, Internal Audit Marlborough, MA, United States Are you a seasoned quality and compliance professional with a passion for driving excellence in regulated ... implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and...MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance in regulated… 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 ... Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA 's guidance documents, and including requirements that are relevant… more
- Merck (Boston, MA)
- …activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy. + Providing quality advice to ... & Development) by: + Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel… more
- Sanofi Group (Cambridge, MA)
- …and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion ... promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable. + Provides US RA AdPromo strategic guidance and… more
- Sanofi Group (Cambridge, MA)
- …Review Committee (MMRC) and Promotional Review Board (PRB). + Ensure full compliance with all corporate and industry policies and legal and regulatory requirements, ... action, competitively positions assigned products and is consistent with applicable FDA regulations and company policies for advertising and promotion of… more
- Philips (Cambridge, MA)
- …technical debt and prioritizing customer-centric non-functional requirements. + Ensure software compliance with medical regulatory standards like FDA , MDR, IEC ... AI-powered medical software solutions that adhere to the highest regulatory and quality standards. **Your role:** + Lead clinical imaging software architecture with… 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 ... Duties and Responsibilities** + Defines submission outlines, content, format, and quality requirements for electronic submissions. + Manages the tracking, compiling,… more
- Fresenius Medical Center (Waltham, MA)
- …+ Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory bodies, to maintain market access and product ... with business objectives and drive the timely delivery of high- quality pharmaceutical products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + **Regulatory Strategy… more
- North Coast Seafoods (Boston, MA)
- …and maintenance work. + Safety & Compliance : Enforce safety regulations and compliance with OSHA, FDA , USDA, and GMP standards in a seafood manufacturing ... of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer… more
Recent Jobs
-
Heavy Equipment Mechanic 2 - Equipment Development Center
- State of Montana (Missoula, MT)
-
Building Substitute 2025-2026 School Year
- Greece Central School District (North Greece, NY)
-
Clinical Trainee or Licensed Therapist - Day Treatment
- Catholic Charities of the Diocese of St. Cloud (Elk River, MN)
-
Director, Business & Legal Affairs
- Sony Pictures Entertainment (Culver City, CA)