As a professional QM/RA associate, you will be responsible for the following tasks:
- Support and collaborate across all areas of Quality Management (QM).
- Ongoing control, improvement, and optimization of quality management processes and standards.
- Assist in creating and reviewing deviation reports, risk management plans, and CAPA (Corrective and Preventive Actions), ensuring thorough monitoring of corrective actions.
- Ensure the implementation and monitoring of regulatory requirements for medical devices.
- Assist with international product certifications and approvals.
- Liaise with regulatory bodies and authorities, including correspondence with notified bodies (globally).
- Support clinical evaluations, ensuring that medical devices meet clinical safety and performance requirements in accordance with regulatory standards.
- Participate in post-market surveillance activities, including monitoring product performance in the market and managing feedback loops to continuously improve device safety and effectiveness.
- Support internal and external audits as well as supplier audits.
- Assist R&D with documentation and support the development process.