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
If you have any questions, contact the recruiter: Jakub (
[email protected])
Furthermore we would like to inform you that the company has an internal reporting procedure, which is available at: demantcompliance - Make a report (codeofconduct.app)
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