Hybrid Quality Assurance, Regulatory Affairs Specialist – German

Posted 3 hours ago

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About the role

  • 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

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

No Education Requirement

Location requirements

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