- Chemours (Boston, MA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- ConvaTec (Lexington, MA)
- …implementing process improvements for regulatory affairs systems. + Experience of regulatory requirements for medical devices containing animal derived ... and sign truthful and accurate technical documents to support device registrations for all business units. To raise orders...materials preferred. + Experience of regulatory requirements for medical Devices … more
- Hologic (Marlborough, MA)
- …science related field preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience ... + Demonstrated proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device or IVD space. + Solid computer skills 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...and all key stakeholders including R&D, Product Management, Quality, Medical & Clinical Affairs, and other functions at all… more
- Medtronic (Mansfield, MA)
- …This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge ... and experience with reviewing advertising and promotional materials for medical devices . The initial project scope for this employee will be related to … more
- Canon USA & Affiliates (Boston, MA)
- …Good PC skills, including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum ... ** Regulatory Affairs Specialist - Post Market - req1434**...$72,000 to max $116,100 (annual equivalency) **_About us!_** _Canon Medical Systems USA, Inc., a world leader in diagnostic… more
- Sanofi Group (Cambridge, MA)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... to internal regulatory processes and procedures for medical devices and combination products. + Engage...regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus. **Job Duties** + Facilitate ... **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory. Minimum of 10 years with BS/BA, or 7… more
- Hologic (Marlborough, MA)
- …continuous improvement of regulatory compliance for our capital equipment medical device portfolio. Working cross-functionally with R&D, Quality, Clinical, ... submissions, license renewals, audits, and inspections for capital equipment medical devices + Review and update labeling,...5-8 years' regulatory affairs experience in the medical device industry, ideally with capital equipment… more
- Philips (Cambridge, MA)
- …+ **Compiles** and **analyzes** clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. ... 4, EU Medical Device Regulation). + **Author** and **maintain** clinical documentation, including Clinical Evaluation Plans and Clinical Evaluation Reports,… more