Quality Assurance & Regulatory Affairs Specialist (with German)

If you want to:

• Work in a key role supporting Quality Assurance and Regulatory Affairs activities with external partners
• Influence how QMS, audits, documentation control and biocompatibility coordination are handled across Demant and 3rd‑party partners
• Join an international organization with Scandinavian work culture based on openness, trust, and collaboration

We are waiting to hear from you!

We are looking for a Quality & Regulatory Affairs Specialist to support our quality and regulatory activities between Demant and our 3rd‑party business partners.

Working with us, you will receive:

• Full‑time employment in a stable, international organization
• Learning & development opportunities tailored to your growth
• Hybrid work model with an office in Szczecin City Center
• Flexible working hours
• Benefits package (private medical care, life insurance, sports card, etc.)
• Scandinavian work culture – informal, collaborative, focused on equality and work‑life balance

What tasks are waiting for you?

• Support the 3rd‑party business with QA and RA‑related activities
• Maintain documentation to support audit activities between 3rd‑party partners and Demant
• Maintain and update 3rd‑party MDF documentation
• Support preparation of management review inputs
• Coordinate regulatory monitoring, assessments, and decisions between Demant and its partners
• Coordinate Biocompatibility activities with internal and external stakeholders

Apply today if you:

• have strong attention to detail and a structured approach to work
• understand quality standards and regulatory frameworks (ISO 13485, MDR 2017/745, MDSAP)
• communicate clearly and professionally
• can work effectively with cross‑functional teams
• have strong documentation management skills
• have good command of German and English
• have experience within the medical devices industry (preferred)

It would be nice if you:

• worked with QMS processes in a regulated environment
• have knowledge of regulatory requirements related to product submissions