- Hologic (Marlborough, MA)
- …lead design controls, risk management processes, and rigorous verification and validation (V&V) strategies, ensuring our software meets the highest global regulatory ... innovation. **Knowledge:** + Deep understanding of global medical device software regulations, including FDA 21 CFR Part 820, EU MDR, ISO 13485, and IEC 62304. +… more
- Hologic (Marlborough, MA)
- …Lifecycle Management System is beneficial. + Advanced knowledge of FDA -Medical Devices-820 Quality System Regulation, especially Design Control requirements, ISO ... Advanced knowledge of Risk Management + Advance knowledge of verification and validation requirements for a regulated product + Advanced knowledge or requirements… more
- Catalent Pharma Solutions (Chelsea, MA)
- …senior engineering staff. The candidate takes ownership of automation engineering, design, validation , and the implementation of new control systems to achieve cost ... assessments and GMP evaluations of control systems to ensure they meet FDA requirements. Prepares standard operating procedures for new and existing control… more
- Medtronic (Boston, MA)
- …lifecycle. + Ensure compliance with all relevant regulatory requirements, including FDA , ISO, and other international standards, and participate in regulatory audits ... and inspections. + Oversee validation and verification activities, including the development of test...Advanced degree preferred. + **Regulatory Knowledge:** In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant… more
- Nanobiosym, Inc. (Cambridge, MA)
- …the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with details of ... process control + Electromechanical experience is required + Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment + Good communication… more
- Nanobiosym, Inc. (Cambridge, MA)
- …products and processing thru numerous manufacturing steps. + Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations. + Provide ... statistical process control + Recent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environment + Strong written and… more
- Carrier (Beverly, MA)
- …+ Interpret and monitor global regulatory requirements (eg, CE/MDR, FDA , ISO standards, environmental/transport regulations, wireless communications, data security). ... development teams. + Engage early in design, risk management, verification/ validation , labeling, packaging, marketing claims, and manufacturing changes. + Support… more
- Bristol Myers Squibb (Devens, MA)
- …complies with company policies, EHS safety procedures, and regulatory requirements ( FDA , OSHA, EPA). + Collaborates with multidisciplinary teams to support facility ... projects, equipment upgrades, and validation /commissioning activities. + Maintains tools, equipment, and work areas clean, organized, and safe. Daily contact with… more
- Catalent Pharma Solutions (Chelsea, MA)
- …manufacturing. The candidate provides support in automation engineering, design, and validation . The Automation Engineer II contributes to the design and ... Part11 assessments and GMP evaluations of control systems to ensure they meet FDA requirements + Prepares standard operating procedures for new and existing control… more
- Fresenius Medical Center (Lawrence, MA)
- …and Regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning and implementation of risk ... of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and validation… more