- 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 ... for mechatronics products. + Experience with contract manufacturing, PCB design/ validation , and lab equipment. + Experience with in-circuit emulators, JTAG… more
- Chiesi (Boston, MA)
- …regulatory submissions through external control arms, patient stratification, and endpoint validation . + Identify opportunities to use RWD to optimize trial ... Compliance: + Ensure RWE studies meet regulatory standards (eg, FDA , EMA guidelines) for use in submissions and decision-making...to have + Experience working with regulatory agencies (eg, FDA , EMA) on RWE submissions. + Knowledge of health… more
- GRAIL (Boston, MA)
- …and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change ... and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US...and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US… more
- Globus Medical, Inc. (Methuen, MA)
- …system integration. + Drive requirements management, risk analysis, and design verification/ validation . + **Leadership & Development** + Recruit, mentor, and develop ... transfer from R&D to production under ISO 13485 and FDA guidelines. + **Innovation & Continuous Improvement** + Identify...and real-time control systems are preferred + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA… more
- 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
- 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 ... standards. + Maintain documentation for design controls, verification, and validation activities. + **Innovation & Research** + Stay current...Medical Image Processing is a plus + Knowledge of FDA 21 CFR Part 11, IEC 60601, and HIPAA… more
- Jabil (Clinton, MA)
- …specifications, developing design verification testing protocols, and executing design validation studies. Additional activities of importance include the support of ... Regulatory Requirements - Test Method Development - Design Verification and Validation - Design Platforming and Issue Resolution - Post-launch Product Engineering… more
- Eurofins US Network (Norwood, MA)
- …and align testing strategies with broader business goals. + **Method Development & Validation :** Oversee the creation and validation of new analytical methods ... and Ion Chromatography** + **Regulatory Knowledge:** Deep understanding of **CPSC, FDA , USP** , and environmental standards like **PFAS** regulations. **Additional… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... audit, assessments, forecasting and special projects, as needed + Manage chargeback validation and rebate processing to ensure accurate and timely payments +… more
- J&J Family of Companies (Danvers, MA)
- …teams to define specifications, develop prototypes, and oversee design validation activities. + External Product Development Collaboration: Partner with external ... Compliance: Ensure all development activities meet applicable regulatory standards ( FDA , ISO, etc.) and internal quality requirements. Prepare documentation for… more