
R&D Device Development Process Manager
3 days ago
The ideal candidate will be responsible for implementing and maintaining design and development processes to ensure regulatory compliance and industry best practices.
Main Responsibilities- Develop and update design control documentation including design plans, input requirements, and traceability matrixes.
- Drive continuous improvements in the device design control process to achieve best-in-class efficiency and effectiveness.
- Coordinate cross-functional team meetings and collaborate with project managers, risk managers, and chief design experts.
- Participate in risk management activities and provide expertise during audits and inspections.
- Ensure successful execution of development projects by collaborating with cross-functional teams.
- Analyze data and develop solutions to improve the design control process.
- Stay up-to-date with regulatory changes and updates.
- Bachelor's degree in Life Sciences or related field.
- 5+ years of experience in device design control.
- Strong written and verbal communication skills.
- Experience with GMP and relevant regulations.
- Knowledge of risk management and usability principles.
- Leadership skills and ability to work in a cross-functional team.
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