- 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
- Hologic (Marlborough, MA)
- Regulatory Affairs Specialist, Medical Device Louisville, CO, United States Marlborough, MA, United States **Join Hologic's Surgical Division as a ... **Experience** + 2-5 years in regulatory affairs, preferably within the medical device industry. + Proven experience preparing regulatory documentation… 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
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… 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
- Fresenius Medical Center (Waltham, MA)
- …issues and broad design matters. + Understands and interprets US and international medical device regulatory requirements, provides guidance on requirements ... lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and… 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