- CTG (Tewksbury, MA)
- …quickly learn and adapt to new systems. + Customer facing, manufacturing and/or Quality/ Regulatory experience in medical device and/or clinical industries + ... duplicates, assign to relevant functions, identifying and escalating urgent quality and regulatory issues as needed according to QRS guidelines + Escalate key… more
- Philips (Cambridge, MA)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory ...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to work in… more
- Fresenius Medical Center (Lawrence, MA)
- …+ Experience in software development, verification, and standards necessary to meet global medical device regulatory requirements. + Clear understanding of ... and leading a team of software developers to deliver high quality medical device software. Develop and drive a long-term strategic vision for the software… more
- Sanofi Group (Cambridge, MA)
- …(3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device /biotech industry + Knowledge and understanding of complex ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge,...R&D colleagues, as well as other stakeholders (eg, Legal, Medical , Marketing, Communications and Compliance). + Participates in the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** ** Device Clinical Strategy & Risk… 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 ... year + 401(k) with up to 6% match + Comprehensive benefits plan, including medical , dental, vision, and more + Fully subsidized Bachelors degree programs paid up… more
- Tufts Medicine (Boston, MA)
- …clinical investigations and trials. 3. Ensure preventive maintenance is performed by Medical Engineering in compliance with regulatory requirements. 4. Provide ... Ventricular Assist Devices (VADs) and VAD-related equipment. Responsible for device tracking, supply utilization and ordering, preventative maintenance, coordinating… more
- Medtronic (Newton, MA)
- …and debugging software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software ... that enhance the usability and functionality of our advanced medical devices. The Senior Software Engineer will be a...The Affera Mapping and Ablation System is an innovative medical technology designed to treat patients with cardiac arrhythmias.… more
- Children's Hospital Boston (Boston, MA)
- …accurate documentation of service actions in compliance with departmental policies and regulatory standards. + Ensures medical device management aligns ... including inspections and calibrations, on a wide variety of electromechanical medical equipment across the satellite locations. Assists with servicing complex and… more
- Integra LifeSciences (Braintree, MA)
- …with building management systems (BMS) and automated environmental controls. + Knowledge of regulatory requirements in the medical device or pharmaceutical ... 5-10 years of experience in experience in refrigeration maintenance, preferably in a medical device or regulated manufacturing environment. + Strong knowledge of… more