- Olympus Corporation of the Americas (Westborough, MA)
- …for Human Factors in Medical Device and healthcare regulations including the FDA 2016 Guidance, 'Applying Human Factors and Usability Engineering to Medical Devices ... Guidance for Industry and Food and Drug Administration Staff ', the FDA 2022 Guidance, 'Content of Human Factors Information in Medical Device Marketing Submissions… more
- Takeda Pharmaceuticals (Lexington, MA)
- …work is done in compliance with IEC 62366 & regulatory body (example, FDA ) expectations. Drive HF/UX initiatives in early stage, development, and LCM projects, ... Human Factors formative and summative studies. + Familiarity with IEC 62366-1/2, FDA HF Guidance, EU MDR usability expectations + Working knowledge of relevant… more
- Hologic (Marlborough, MA)
- …of Quality Management Systems (QMS) and electronic documentation systems. + Expertise in FDA 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and other global ... degree in Quality Assurance or a related field. + Prior experience in FDA , Notified Body, ISO, or other regulated manufacturing settings is beneficial. + Proven… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …the drug, biologic, and device development process, laws, regulations, and guidelines from FDA , EMA, PMDA, ICH, etc. + General knowledge of global regulations for ... 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and Competencies:** +… more
- Philips (Cambridge, MA)
- …of 10+ years' experience in Design Quality Engineering /Risk management for FDA regulated Medical Device (21 CFR 820, ISO 13485/14971) New Product ... Quality Engineering teams. + You have extensive experience engaging with FDA investigators, other external regulators/auditors during inspections/audits and able to… more
- Insight Global (Westborough, MA)
- …as applicable. The role ensures these tools align with regulatory requirements (eg, FDA , IEC 62304, ISO 13485) and supports system access via Single Sign-On (SSO) ... knowledge of compliance frameworks relevant to SaMD (IEC 62304, ISO 13485, FDA CFR Part 11). * Excellent communication, problem-solving, and documentation skills. *… more
- Catalent Pharma Solutions (Chelsea, MA)
- …of International Quality and Compliance standards and requirements, with preferable FDA experience; + Demonstrated knowledge of Change management and Lean ... Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, IBM, FDA , USDA; + Ability to work under pressure to meet tight and changing deadlines;… more
- ThermoFisher Scientific (Waltham, MA)
- …specifically device master files, regulatory support files, and meeting requests to FDA and other regulatory bodies. + Provide regulatory direction to product ... + Extensive knowledge of regulatory requirements, including those from the FDA , Health Canada, and other regions, particularly concerning pharmaceutical raw… more
- Charles River Laboratories (Wilmington, MA)
- …service and compliance documentation as required by company policy, cGMP and FDA . * Responsible for resolving client testing laboratory instrument service issues. ... proudly supported the development of ~85% of the drugs approved by the FDA in 2019. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + **Regulatory & Quality Compliance** + Ensure adherence to IEC 62304 ... Imaging, Surgical Navigation or Medical Image Processing is a plus + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA compliance. + Strong communication and… more