- Hologic (Marlborough, MA)
- …+ In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory ... a focus on integrity and compliance. **Experience:** + Minimum 12+ years in the medical device industry. + Proven track record in quality system strategy, risk… more
- Hologic (Marlborough, MA)
- …a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director of ... in FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and Medical Device Directive. + Familiarity with ISO 14970, IEC 60601, IEC… more
- Hologic (Marlborough, MA)
- …companies + Passionate about global privacy and data protection law, as well as medical device technology policy more broadly + A passion for people management, ... our global security platform a solid differentiator in the Medical Technology industry. With your passion and energy in...to the Product team on product offerings, Commercial and R&D teams for new services and /or customer engagements,… more
- Danaher Corporation (Boston, MA)
- …regulations on the development and registration activities for the respective medical products + Develop and manage regulatory submissions (eg, 510(k), PMA, ... secure product approvals. + Collaborate cross-functionally and globally with Clinical Affairs, R&D , QA, and Business Development to align regulatory plans with, and… more
- ConvaTec (Lexington, MA)
- …a research emphasis on biointerfaces and regenerative engineering + Experience in medical device developing and testing **Travel Requirements** Position requires ... Pioneering trusted medical solutions to improve the lives we touch:...occasional travel (0-10%). Expected trips include manufacturing and R&D sites (Dominican Republic, Slovakia, Deeside) as well as… more
- Norstella (Boston, MA)
- …leading providers of data and intelligence on clinical trials, drug treatments, medical devices and what's new in the regulatory and commercial landscape. Relying ... on us to deliver vital advantage when making critical R&D and commercial decisions, our customers come from over 3000 of the world's leading pharmaceutical, contract… more
- Teleflex (Chelmsford, MA)
- …support capital equipment depot service activity through repairs and maintenance to medical device capital equipment and support Teleflex cardiac customers via ... None **Requisition ID** :12313 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health… more
- Capgemini (Waltham, MA)
- …environment, we'd love to hear from you. **Your role** + Design and develop standalone medical device applications using modern C (C 17 or newer) on Linux OS ... Join Capgemini as an Algorithm Software Engineer and help shape the future of medical innovation. In this onsite role based in Boston, MA, you'll contribute to the… more
- Norstella (Boston, MA)
- …global company providing outstanding market intelligence services for the Pharmaceutical, Medical Device , Financial and Consulting sectors, through the Evaluate ... timely and accurate analysis of reported drug sales, consensus sales forecasts, R&D pipeline, markets and comprehensive company financials. To amplify the ability to… more
- Sanofi Group (Cambridge, MA)
- …**About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of **relevant ... Establishes and develops key internal relationships with therapeutic product leaders in R&D and Corporate to foster open communication and teamwork. + Assures… more