- Hologic (Marlborough, MA)
- …science related field preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience ... with some complexity. + Demonstrated proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device or IVD space. +… 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 work in… more
- Philips (Cambridge, MA)
- …the right fit if:** + You've acquired 10+ years of experience working in Regulatory Affairs within the medical device industry; Experience with ... **Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)** The...Affairs and all key stakeholders including R&D, Product Management, Quality , Medical & Clinical Affairs, and other… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- … submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Takeda Pharmaceuticals (Lexington, MA)
- …a group of regulatory individuals to ensure timely delivery of high quality of regulatory dossiers and strategies according to agreed business priorities. + ... Advanced Degree (MS), with Ph.D. preferred. + 15+ years of seasoned biopharmaceutical/ device industry experience or with a regulatory agency, while leading… more
- Sanofi Group (Cambridge, MA)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge,...+ Dealt effectively with cross-functional groups, which may include Medical , Legal, Marketing, etc. + Experience managing others is… more
- Fresenius Medical Center (Waltham, MA)
- …regulatory compliance, quality engineering and auditing in the pharmaceutical or medical device sector or related industries + Several years of practical ... Fresenius Medical Care policies and procedures to drive continuous quality improvement. Support external quality management inspections at Fresenius … more
- AbbVie (Waltham, MA)
- … to prepare submissions and partic + Makes key decisions on product quality , compliance and regulatory conformance issues for sterile, biological, liquid, ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...or letters of intent to ensure that the appropriate quality , compliance and regulatory aspects are met… more
- Fresenius Medical Center (Lawrence, MA)
- …**PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ensure ... product development or on design changes to ensure product quality and minimize risk to users and patients as...minimize risk to users and patients as well as regulatory and corporate SOP compliance. . Reviews and approves… more
- Boston University (Boston, MA)
- …assurance monitoring and auditing on human research studies conducted at BMC and BU Medical Campus. The Human Research Quality Manager will evaluate and verify ... this individual will provide assistance to clinical researchers regarding regulatory aspects to the conduct of research throughout the...on human research studies conducted at BMC and BU Medical Campus. The Human Research Quality Manager… more