Quality & Regulatory Affairs Specialist – Medical Devices

About the role

Neuroth is seeking a motivated Quality and Regulatory Affairs Specialist to support its growing medical‑device and hearing‑protection activities in Serbia. The role combines operational, quality‑assurance and regulatory responsibilities and is designed as a development path toward senior quality and distribution leadership.

Key responsibilities

• Ensure compliance with Serbian and international medical‑device regulations, maintaining up‑to‑date regulatory documentation.
• Manage quality‑system activities including incoming‑goods inspection, in‑process and final release, deviation handling, CAPA, and root‑cause analysis.
• Oversee GDP‑compliant storage and distribution, documentation of deliveries, recalls and supplier qualification.
• Support internal and external audits, risk‑management activities and calibration/qualification programmes.
• Coordinate with production to verify work‑instruction adherence, batch documentation and traceability.
• Train employees on quality‑management and regulatory topics and contribute to cross‑functional projects.

Required profile

• University degree in engineering, biomedical, pharmacy, chemistry, quality management or a comparable technical field.
• Minimum 2 years of professional experience in a regulated environment, preferably medical devices.
• Familiarity with ISO 13485, medical‑device registration processes and Good Distribution Practice.
• Strong Serbian language skills and good English (or German) communication abilities.

Required skills

• Knowledge of ISO 13485 quality‑management standards.
• Experience with ERP/DMS/QMS systems.
• Proficiency in Microsoft Office suite.
• Understanding of risk‑management, CAPA and traceability procedures.
• Ability to conduct root‑cause analysis and effectiveness checks.