- Takeda Pharmaceuticals (Lexington, MA)
- …+ Coordinate risk mitigation activities across clinical, regulatory, quality , and engineering functions + Perform safety reviews on device and combination ... Serve as clinical liaison to Global Device Team, including engineering , regulatory affairs, quality , and commercial functions + Coordinate interdepartmental… more
- Takeda Pharmaceuticals (Lexington, MA)
- …ISO 13485, ISO 14971, MDR/IVDR, MDSAP). + Act as or designate the Device Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance ... + Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring… more
- Oracle (Boston, MA)
- … device -level safety, performance, and compliance needs. + Regulatory Compliance & Quality Alignment + Ensure adherence to medical device software standards ... record of mentoring and guiding engineers, fostering adoption of compliant and high- quality software engineering practices. Disclaimer: **Certain US customer or… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the best of my knowledge. **Job Description** **Primary** **Role:** The Staff Device Engineer will lead technical efforts for combination products and drug delivery ... device projects with limited oversight. As a hands-on technical...matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and… more
- Sanofi Group (Framingham, MA)
- …as the primary liaison with regulatory authorities. You'll collaborate across R&D, Device , Manufacturing, and Quality teams while preparing high- quality ... to work effectively in a matrix environment, engaging cross-functionally with R&D, Device , Manufacturing, and Quality teams. Demonstrates business acumen, strong… more
- Sanofi Group (Cambridge, MA)
- …assessments, and interact with regulatory authorities. You'll collaborate across R&D, Device , Manufacturing, and Quality teams while preparing high- quality ... to work effectively in a matrix environment, engaging cross-functionally with R&D, Device , Manufacturing, and Quality teams. Demonstrates business acumen, strong… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Title: Senior Manager, Combination Products and Device Manufacturing** **Location: Cambridge, MA** **About the role:** As a ... Senior Manager, Combination Products and Device Manufacturing, you will manage and provide project and...and lifecycle management activities. + Work closely with R&D, Quality , Regulatory, Procurement, and external suppliers to ensure seamless… more
- Oracle (Boston, MA)
- …up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy, and regulatory ... engineering to ensure patient safety, usability, and compliance across...and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical … more
- Oracle (Boston, MA)
- …up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy, and regulatory ... engineering to ensure patient safety, usability, and compliance across...and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical … more
- Oracle (Boston, MA)
- …degree preferred. + Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or ... and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with product … more