Quality Assurance & Regulatory Affairs Specialist supporting Demant's 3rd-party business partners. Handling documentation, audits, and regulatory coordination within an international organization.
Responsibilities
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
Job title
Quality Assurance, Regulatory Affairs Specialist – German
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