- ZOLL Medical Corporation (Boston, MA)
- …PhD, or equivalent) is preferred. Experience : + 5+ years of clinical or medical device /pharmaceutical industry experience. Required. + 7+ years of experience in ... professional relations, medical affairs, or healthcare marketing, with a focus on cardiovascular or cardiac solutions . Preferred. + Proven track record of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …regulatory strategies and requirements for digital health products and solutions, ensuring compliance with global medical device regulations. As part ... compliance frameworks, and internal regulatory guidance specific to non- medical device digital health initiatives. + Design...lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare … more
- Terumo Medical Corporation (Boston, MA)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers...Prior experience as a Field Clinical Specialist with a medical device company is preferred. + Prior… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and maintain SOPs, compliance frameworks, and internal guidance tailored to non- medical device digital health initiatives. + Design and deliver regular ... and digital health solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies aligned with the… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... enterprise quotes. + Understand the specialized requirements for quoting regulated medical software, hardware, and consulting; ensuring accurate compliance ,… more
- Sodexo (Hyannis, MA)
- …and medical device manufacturers to ensure medical device security while supporting regulatory compliance . This is a hands-on role requiring ... role is responsible for the technical execution of cybersecurity initiatives across medical device inventories in hospital and clinical environments. You will… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and expert understanding of the principles, standards and guidance for Human Factors in Medical Device and healthcare regulations including the FDA 2016 ... teammate, a mentor and hands-on multi-disciplinary technical leader with a strong medical device background and excellent communication skills. This position… more
- Olympus Corporation of the Americas (Westborough, MA)
- …teams, the RA Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, ... of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of...lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare … more
- Globus Medical, Inc. (Methuen, MA)
- …expend effort to meet schedules and deadlines * Experience working for a medical device manufacturer preferred * Excellent verbal and written communication ... Position Summary: The Production Technician is responsible for assembling electro-mechanical medical devices in compliance with applicable FDA, state, OSHA,… more
- Medtronic (Mansfield, MA)
- …conducting regulatory change assessments, and supporting the implementation of the EU Medical Device Regulation (MDR). The Sr. RAS translates regulatory ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...with 4+ years of regulatory affairs experience in the medical device , biotech or pharmaceutical industry OR… more