The head of the QM & RA department leads the Quality Management and Regulatory Affairs team, ensuring adherence to regulatory standards and continuous development of the quality management system (QMS). This role encompasses management tasks, strategic oversight, and operational responsibilities, acting as a liaison between management, internal departments, and external stakeholders.
Main Tasks:
Leadership and Team Management:
- Oversee the QARA department, including vacation and absence planning.
- Organize tasks and projects to ensure effective team collaboration.
- Serve as an interface between management, other departments, and team members to achieve organizational goals.
- Promote clear and effective communication within and outside the team.
Quality Management:
- Maintain, monitor, and further develop the quality management system (DIN EN ISO 13485).
- Oversee the creation, maintenance, and updating of product technical documentation.
- Ensure compliance with all regulatory requirements, particularly EU Regulation 2017/746 (IVDR).
- Implement and monitor post-market surveillance processes.
- Manage CAPA (Corrective and Preventive Action), root cause analysis, and complaint management.
- Act as management representative and lead the review of the quality management system.
- Conduct trend analyses of the quality management system and present data to management.
- Manage device history recording and document control activities.
- Ensure business operations comply with applicable regulations and provide guidance for continuous process improvement.
Regulatory Affairs:
- Coordinate and ensure compliance with all company regulatory requirements.
- Act as Person Responsible for Regulatory Compliance (PRRC) as per internal appointment letter.
- Coordinate product registrations, including documentation for national and international markets.
- Prepare certificates and confirmations for distributors, including notarial certifications where necessary (excluding contracts).
- Manage recalls and safety advisories on-site.
Security and Compliance:
- Act as deputy radiation protection officer to ensure compliance with radiation protection requirements.
- Consult as a medical device consultant.
- Conduct internal audits to ensure compliance with the QMS and regulatory standards.
Qualifications:
- Bachelor's or Master's degree in Biotechnology, Biopharmaceutical Technology, or a related field.
- At least 3 years of experience in technical documentation, regulatory affairs, or quality management.
- Certified Internal Auditor.
- Knowledge of radiation protection (S1.1-1.3, S2.1, S6.1).
- Completed PRRC training (2024) or willingness to complete it.
- Knowledge of DIN EN ISO 13485 and EU IVDR standards.
- Leadership and team management skills.
- Analytical and organizational skills.
- Fluent in German and English
