Regulatory Affairs Manager (m/w/d)

Manage regulatory strategy and implementation for product approvals across EU-MDR, FDA, and international markets. Create and maintain technical documentation in compliance with ISO 13485, MDR, and 21 CFR 820. Communicate with international authorities and named entities while supporting product development projects regarding regulatory requirements. Collect and maintain clinical data, monitor changes in regulatory standards, and prepare for audits and inspections. This role involves working within a decades-old medical technology company developing high-quality products for the global market, offering a responsible and varied position with significant autonomy in shaping the quality strategy.