Short Description
For Neuroth, one of the leading international companies in hearing acoustics, we are looking for a motivated candidate for the position of Quality and Regulatory Affairs Specialist (QM/QS) for Medical Devices.
- To support the development of our manufacturing and wholesale activities in the field of medical devices and hearing protection in Serbia, we are looking for a versatile professional for quality management, quality assurance, and regulatory affairs.
- As this is a growing company, this position combines operational, quality assurance, and regulatory responsibilities. The role is designed so that, in the medium to long term, the person will meet the requirements to assume the function of:
- Responsible Person for Quality (manufacturer of medical devices)
- Responsible Person for Wholesale Distribution of medical devices
Description
Regulatory Affairs
- Support compliance with Serbian and international medical device regulations
- Maintain regulatory documentation
- Support registrations, authority requests, and inspections
- Monitor regulatory requirements and changes
- Support vigilance and reporting systems
- Monitor GDP-compliant storage and distribution
- Ensure documentation of deliveries and recalls
- Support supplier qualification and monitoring
- Participate in recall and crisis processes
- Monitor incoming goods, in-process, and final inspections
- Release materials, components, and products in accordance with internal procedures
- Handle deviations, complaints, and CAPA measures
- Support root cause analysis and effectiveness checks
- Organize calibrations and qualifications
- Support internal and external audits
- Manage and communicate quality KPIs to employees and headquarters
- Monitor compliance with work instructions and process requirements
- Review batch documentation
- Ensure traceability
- Participate in product transfers and process validations
- Train employees on quality management and regulatory topics
- Participate in the risk management team
- Contribute to projects related to company development
- Support other business areas according to qualificatio
Requirements
- Completed university degree in one of the following fields:
- 2 years of professional experience in a regulated environment
- Experience with medical devices
- Experience in quality management
- Experience in production or quality control
- Experience with ISO 13485 or comparable standards
- Basic understanding of a documented quality management system
- Practical experience in quality assurance, quality control, production, laboratory, engineering, or regulated distribution.
- Confident handling of deviations, CAPA, risk analyses, inspection plans, traceability, and controlled documents.
- Ability to perform operational tasks independently while building simple, scalable processes in parallel.
- Experience with ERP/DMS/QMS systems is an advantage.
- Good knowledge of Microsoft Office
- Very good Serbian language skills
- Good English and/or German language skills
- Basic knowledge of ISO 13485
- Understanding of risk management and documentation
- Independent working style
- High level of initiative
- Structured and precise working style
- Sense of responsibility
- Solution-oriented thinking
- Strong communication skills
- Willingness to take on multiple roles in a start-up organization
- Responsible Person for Quality
- Responsible Person for Wholesale Distribution
