Quality Assurance, Regulatory Affairs Specialist – German
Demant
full-time
Posted on:
Location Type: Hybrid
Location: Szczecin • Poland
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About the role
- 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
Requirements
- 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)
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assuranceregulatory affairsdocumentation managementbiocompatibilityISO 13485MDR 2017/745MDSAP
Soft Skills
attention to detailstructured approachclear communicationcross-functional teamwork