- System One (Devens, MA)
- …air helmet. + Accurately complete batch records and documentation in compliance with FDA and cGMP guidelines. + Ensure all production and support equipment is ... field (entry-level to 2+ years' experience) + Strong understanding of GMP and FDA regulatory requirements + High level of safety awareness in an industrial or… more
- Olympus Corporation of the Americas (Westborough, MA)
- …analysis, etc. required for new and existing products. + Working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they ... in Geometric dimensioning and tolerance. + Must have working knowledge of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they… more
- Spindrift (Newtonville, MA)
- …agreements, sustainability matters, website copy and marketing materials + Advise on FTC, FDA , and related regulations for food & beverage products + Mitigate risks ... law, trademark/IP, employment law, and privacy/data protection + Familiarity with FDA /FTC regulatory frameworks for food/beverage marketing + Excellent judgment and… more
- Biomat USA, Inc. (Worcester, MA)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attends… more
- Integra LifeSciences (Boston, MA)
- …Action/Preventive Actions (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned. **DESIRED ... other cGMP regulated product preferred environment. + Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality… more
- Philips (Cambridge, MA)
- …+ You've acquired a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a focus on the development ... You have detailed knowledge of medical device regulations, requirements, and standards for FDA and EU especially for medium risk devices (Class II/Class IIA) focused… more
- Rhythm Pharmaceuticals (Boston, MA)
- …NDA/IND commitments + Act as an expert resource for eCTD submissions to FDA , ensuring compliance with internal and health authority standards + Support the ... Knowledge and understanding of the drug development process + Strong knowledge of FDA and Global EU/UK regulations and guidelines, especially CTD and eCTD structure… more
- Medtronic (Boston, MA)
- …Ensure all software verification activities adhere to relevant medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485, IEC 62304) and internal quality ... career development. + Experience in medical software regulation such as (ISO 13485, FDA 21 CFR Part 820). **Physical Job Requirements** The above statements are… more
- Sanofi Group (Cambridge, MA)
- …written communication skills. + Strong understanding of clinical trials processes and FDA approval processes, including accelerated approval, and FDA and other ... regulations and guidance governing commercial promotional material and medical scientific exchange. + Experience with developing and executing US expanded access protocol + Ability to build solid working relationships with commercial organizations and… more
- Eliassen Group (Marlborough, MA)
- …all design and development activities adhere to regulatory requirements (eg, FDA , CE, MDR), and maintain detailed, accurate documentation throughout the product ... development, testing, and integration. + Knowledge of medical device **regulations** (eg, FDA , ISO 13485, IEC 62304) and design control processes. + Strong… more