- BeOne Medicines (Cambridge, MA)
- …development plans and risk assessments, critical issue management and advice on FDA Health Authority interactions. + Uses extensive knowledge of US, and ICH ... in conformance with local regulatory requirements. + Liaises and negotiates with FDA as needed for all aspects pertaining to drug development including resolution… more
- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you ... lasting impact on patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO standards (eg, ISO… more
- Fresenius Medical Center (Waltham, MA)
- …to ensure timely approval and market access across key regions (eg, FDA , EMA, Health Canada, etc.). Including global chemistry, manufacturing, and controls writers ... products. + Ensure compliance with local and global regulatory standards, including FDA , EMA, ICH, and other regulatory bodies, to maintain market access and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Government Laws and Regulations. This includes US Customs and Border Protection, USDA, FDA , Fish Wildlife, Public Health, Bureau of Industry and Security, DEA, FAA ... Tariff Codes, Export Commerce Control Number (ECCN), PGA Licenses & Permits, FDA product codes, INDs for raw materials, chemical intermediates, and finished goods.… more
- J&J Family of Companies (Danvers, MA)
- …as the subject matter expert (SME) for process validation, ensuring alignment with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations and standards. ... both manual and automated assembly processes. + Strong working knowledge of FDA , ISO, and GHTF validation requirements, including IQ/OQ/PQ frameworks. + Proven… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Performance Food Group (Taunton, MA)
- …+ Complies with local, state, and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **Req Number:** 126068BR **Address Line 1:** 225 John Hancock Road ... ability, experience with budgeting and profit and loss * Experience with OSHA, FDA , USDA and other regulatory agencies * Experience with Microsoft Office including… more
- US Tech Solutions (Quincy, MA)
- …Maintain basic knowledge of information required to appear on packaging per USDA, FDA , FTC, and State level laws **Knowledge, Education & Experience** + Preferred ... & Abilities** + Basic Knowledge of product and food labeling (USDA, FDA , FTC, State) + Excellent communication and prioritization skills + Project Management… more
- Charles River Laboratories (Boston, MA)
- …guidelines and standards that relate to animal care and use (Eg, USDA, FDA , AAALAC). + Make recommendations and assist in establishing and enhancing veterinary and ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Eliassen Group (Westborough, MA)
- …strength of materials, FEA, risk analysis). . Maintain strong working knowledge of FDA 21 CFR 820, ISO 14971, IEC 60601, GMP, and related standards. **Experience ... Proficient in Geometric dimensioning and tolerance . Strong working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as… more