Quality and Regulatory Affairs Manager
About the Role
Regulatory Affairs and Quality Management Manager
Are you interested in digital health applications and want to develop further within Regulatory Affairs and Quality Management?
Our client is looking for a RAQM Manager to support the implementation of regulatory requirements and ensure the compliant development of cutting-edge medical products in the digital healthcare.
- Conduct cross-departmental maintenance and optimization of the QM system in accordance with ISO 13485:2016 and EU-MDR 2017/745.
- Creation, review, and maintenance of technical documentation according to EU MDR for cutting-edge medical devices.
- Plan, gather, and implement regulatory requirements, ensuring compliance with approval regulations in both the EU and international markets.
- Strategically plan, execute, and evaluate external and internal audits.
What is required:
- A relevant scientific or technical degree.
- Initial professional experience in regulatory affairs and/or quality management, with a preference for SaMD experience.
- Excellent oral and written communication and presentation skills in both German and English.
What You Can Expect from Us:
- Embrace a startup mentality, working alongside international colleagues and taking on responsibilities from day one.
- Personal development and flat hierarchies with feedback-oriented culture.
- Competitive remuneration, flexible working hours, unlimited home office options, and additional perks like Deutschland Ticket subsidy and a company pension scheme.
- Relaxed working atmosphere, ensuring your well-being with yoga sessions, international dinners, flexible desks, and modern meeting spaces in the heart of Hamburg.
If this sounds like you, please do not hesitate and send the application.
If you have any questions regarding the position, please contact:
Dominika Wyrwinska at firstname.lastname@example.org