- US Tech Solutions (Tewksbury, MA)
- …learn and adapt to new systems. + Customer facing, manufacturing and/or Quality / Regulatory experience in medical device and/or clinical industries. + ... providing front line support for internal and external customers regarding quality and regulatory related inquiries and issues, and act as liaison between… more
- CTG (Tewksbury, MA)
- …learn and adapt to new systems. + Customer facing, manufacturing and/or Quality / Regulatory experience in medical device and/or clinical industries + ... quickly, identify duplicates, assign to relevant functions, identifying and escalating urgent quality and regulatory issues as needed according to QRS guidelines… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Develop Device Clinical Development Strategy for Combination Products and Medical Devices + Develop comprehensive risk management strategies for devices ... device , or pharmaceutical industry experience + Experience with both medical devices , drug- device combination products, digital health technologies… more
- Sanofi Group (Cambridge, MA)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... properly addressed. + Contribute to internal regulatory processes and procedures for medical devices and combination products. + Engage with the relevant … more
- Medtronic (Billerica, MA)
- …and writing in English. **Preferred Qualifications (Must Have!):** + Prior experience in the medical device or electronics industry. + Knowledge of ISO and FDA ... Billerica site. This role is critical to ensuring the quality and precision of our products. The ideal candidate...up to 6% match + Comprehensive benefits plan, including medical , dental, vision, and more + Fully subsidized Bachelors… more
- Medtronic (Newton, MA)
- …intuitive, user-friendly interfaces that enhance the usability and functionality of our advanced medical devices . The Senior Software Engineer will be a key ... and debugging software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software… more
- Tecomet (Wilmington, MA)
- …facilitate the development of quality systems for a highly regulated medical device , aerospace, defense industries to achieve customer satisfaction, ... (10) to Fifteen (15) years of regulatory affairs and quality systems experience directly in medical devices is required. + Master's degree (desirable but… more
- Fresenius Medical Center (Lexington, MA)
- …regulations. * Maintains corporate regulatory files including EU technical files/documentation ( Medical Device Directives & Medical Device ... for NxStage Medical , Inc. products. Will provide regulatory input into key quality system processes...as a Regulatory Affairs Specialist in the medical device field or (ii) a Master's… more
- Philips (Cambridge, MA)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... reviewed with the RA management. + Driving improvement in regulatory aspects of the Quality Management System...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to… more
- Candela Corporation (Marlborough, MA)
- …RA topics required for both tactical and strategic initiatives. + Possess and exercise regulatory and medical device industry relationships to inform bold RA ... **Director, Global Regulatory Affairs** Requisition Number **2872** Location **US -...sciences/engineering/related field, plus 12 years of experience in the medical device industry with at least 10… more