- 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
- Abbott (Burlington, MA)
- …improvement activities. + Comply with US Food and Drug Administration ( FDA ) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, ... or an equivalent combination of education and experience. + Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304),… more
- North Coast Seafoods (New Bedford, MA)
- …of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit +… more
- J&J Family of Companies (Danvers, MA)
- …compliance. + Regulatory and Compliance Support: Ensure all activities adhere to FDA , ISO, and other relevant standards. Prepare documentation and reports for audits ... + Strong understanding of design controls, risk management, and regulatory requirements ( FDA , ISO). + Exceptional project coordination skills, with the ability to… more
- Rise Baking Company (Worcester, MA)
- …update, and audit sanitation program and all SSOPs to ensure compliance with FDA and GFSI requirements + Assist with updating quality systems relating to sanitation, ... sanitation programs + 2+ years of supervisory experience preferred + GFSI, FDA , and State Department of Agriculture experience preferred + HACCP and PCQI… more
- J&J Family of Companies (Danvers, MA)
- …processing) for precise system operation. + Ensure compliance with IEC 62304, FDA design controls, and other applicable regulatory standards. + Develop and maintain ... laboratory test equipment such as oscilloscopes etc. + Knowledge of regulatory ( FDA , EPA) and quality processes. + Experience with software configuration management… more
- Cardinal Health (Boston, MA)
- …of additional services, and reports adverse events in accordance with FDA and client requirements. **_Responsibilities_** + Educates patients during outbound and ... to organizations or providing information to patients. + In accordance with FDA regulations and client requirements, records adverse events for treatments and… more
- Datavant (Boston, MA)
- …and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3). + Represent Datavant's quality program ... software organizations. + Strong working knowledge of relevant regulations and frameworks, including ** FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** ,… more
- Chiesi (Boston, MA)
- …Regulatory and Compliance: + Ensure RWE studies meet regulatory standards (eg, FDA , EMA guidelines) for use in submissions and decision-making across global markets. ... would prefer for you to have + Experience working with regulatory agencies (eg, FDA , EMA) on RWE submissions. + Knowledge of health policy, payer dynamics, and HTA… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …will participate in US and global integrated brand teams, advising on FDA laws and regulations, anti-kickback and bribery statutes, false claims acts, transparency ... and helping the teams manage and mitigate legal risk. + Advising on FDA laws and regulations, anti-kickback and bribery statutes, false claims acts, transparency… more