- J&J Family of Companies (Danvers, MA)
- …software, and clinical engineers while collaborating with cross-functional partners in Quality , Regulatory , Manufacturing, and Supply Chain. You will translate ... methods; summarize results and provide actionable technical conclusions. + Coordinate with Quality and Regulatory to prepare verification packages for … more
- J&J Family of Companies (Danvers, MA)
- …production equipment. + Ensure calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part 820). ... as needed. **Performance Reporting** + Ensure calibration traceability and compliance with regulatory and quality systems (eg, ISO 13485, FDA QSR 21 CFR Part… more
- Sanofi Group (Cambridge, MA)
- … regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high- quality regulatory submissions, ... relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing… more
- Sanofi Group (Cambridge, MA)
- …part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from ... leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy… more
- Beth Israel Lahey Health (Burlington, MA)
- …knowledge of specific protocols. Implements study protocols in accordance with regulatory , departmental and institutional requirements. Uses the nursing process to ... trials research adhering to Research SOPs, GCP compliance and FDA regulations. 2) Functions as a mentor, resource and...the EMR. + Performs data management duties ensuring strong quality of data. + Identifies data management issues with… more
- Hologic (Marlborough, MA)
- …a meaningful impact on healthcare innovation. **Knowledge:** + Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device ... thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …with regulatory expectations. + Partner with Operations, R&D, and Quality , to ensure alignment of test expectations, supporting documentation, and product ... methods, fixtures, and workflows are reliable, scalable, efficient, and compliant with regulatory standards. This role focuses on building robust, automated test and… more
- Astellas Pharma (Westborough, MA)
- …of qualification and validation procedures and practices in accordance with global regulatory bodies ( FDA , EMA, ICH, Japan guidance), Astellas policies and ... maintained in compliance with user requirements, process parameters and global regulatory guidelines. The successful candidate will foster compliance across a broad… more
- Takeda Pharmaceuticals (Lexington, MA)
- …across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device ... into technical requirements + Coordinate risk mitigation activities across clinical, regulatory , quality , and engineering functions + Perform safety reviews… more
- Element Materials Technology (Acton, MA)
- …and technical requirements. + Interpret and communicate complex testing protocols, regulatory requirements ( FDA , ISO/IEC 17025), and client specifications to ... **Overview** Join Element's **Santa Fe Springs laboratory** , an FDA -registered, ISO/IEC 17025-accredited facility specializing in **pharmaceutical testing, trace-metal… more