- Hologic (Marlborough, MA)
- …science related field preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience ... streamline and enhance efficiency. + Promote a culture of compliance , collaboration and continuous improvement within the regulatory...proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device… more
- Philips (Cambridge, MA)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... Ultrasound Products meet FDA, and other governmental agency/notified body Regulatory Compliance standards/requirements. **Your Role:** + Leads business… more
- Takeda Pharmaceuticals (Boston, MA)
- …years of overall biopharmaceutical/ device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can ... and suppliers to align change control processes with global regulatory expectations. + Ensure site compliance with...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Danaher Corporation (Boston, MA)
- …diagnostic regulations on the development and registration activities for the respective medical products + Develop and manage regulatory submissions (eg, ... provide inputs and updates to, business and clinical goals. + Provide device -specific regulatory insight/guidance during CDx / Pharma partner cross-functional… 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… 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 of ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Trinity Health (Springfield, MA)
- …statements, rosters, etc. + Assists the Director with Joint Commission and other regulatory compliance , documentation, and other related regulatory duties. ... time **Shift:** Day Shift **Description:** Come join the Plant Operations team at Mercy Medical Center, part of Trinity Health Of New England! We are a member of… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …+ Minimum of 10 or more years in life science organizations, ideally in the medical device industry. Knowledge, Skills and Abilities + In-depth knowledge of ... compliance laws, regulations, and best practices, especially those relevant to the medical device industry. + Demonstrated experience as a strategic partner… 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...non-clinical evidence. + **Collaborates** with cross-functional teams to ensure regulatory compliance and to define medical… more
- Insight Global (Danvers, MA)
- …successful at this role the resource must have product labeling experience within the medical device field, managing CAPAs cradle to grave, prior EU MDR ... Privacy Policy: https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements 4+ years of medical device product labeling background SAP, ETQ or… more