R&D Director
Terumo Blood and Cell Technologies
full-time
Posted on:
Location Type: Office
Location: Shanghai • 🇨🇳 China
Visit company websiteJob Level
Lead
About the role
- Lead, coach, and develop a high-performing multi-disciplinary R&D team.
- Foster a culture of collaboration, innovation, accountability, and continuous improvement.
- Develop and maintain strong relationships with CDMO partners to ensure high-quality production and timely delivery of products.
- Monitor, analyze and identify emerging technologies, industry trends, competitor activities, and regulatory pathways to inform strategic R&D plan and decision-making.
- Ensure all design control processes are rigorously followed, and documentation meets both Terumo BCT's internal quality standards and Chinese regulatory requirements (NMPA, ISO 13485, etc.).
- Lead the development and execution of local strategic R&D programs and act as a key stakeholder on broader global programs.
- Act as primary interface with Authorities and be able to interpret, answer and state all product design and product technology relevant affairs during inspection or auditing.
Requirements
- A minimum of a bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related field.
- 15 years’ experience in medical device industry, with at least 5 years in a leadership role managing R&D organization and complex program execution.
- Proven track record of successfully leading the end-to-end development and commercialization of Class II/III medical devices (NMPA or equivalent).
- Strong knowledge of the Chinese healthcare market, including regulatory requirements and industry trends.
- Deep expertise in China NMPA regulatory submission processes and strong knowledge of ISO 13485, FDA QSR, and other relevant medical device standards.
- Strong understanding of Design Control, Change Control, Design Verification and Validation procedure.
- Solid experience in program management with proven track record.
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
mechanical engineeringbiomedical engineeringelectrical engineeringdesign controlchange controldesign verificationdesign validationprogram managementcommercialization of medical devicesregulatory submission processes
Soft skills
leadershipcoachingcollaborationinnovationaccountabilitycontinuous improvementrelationship managementstrategic decision-makingcommunicationproblem-solving