Quality and Regulatory Affairs Specialist (QM/QS) for Medical Devices

Belgrade

Health Care and Pharmaceutical

Flexible

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

Wholesale and Distribution

Monitor GDP-compliant storage and distribution
Ensure documentation of deliveries and recalls
Support supplier qualification and monitoring
Participate in recall and crisis processes

Quality Management and Quality Assurance

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

Production

Monitor compliance with work instructions and process requirements
Review batch documentation
Ensure traceability
Participate in product transfers and process validations

Other Responsibilities

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:

Electrical engineering / mechanical engineering / pharmacy / medicine / biomedical engineering / chemistry / biology / process engineering / materials science / quality management or comparable technical/scientific educationProfessional ExperienceMinimum:

2 years of professional experience in a regulated environment

Preferred:

Experience with medical devices
Experience in quality management
Experience in production or quality control
Experience with ISO 13485 or comparable standards

Minimum Professional Competencies

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.

Knowledge

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

Personal Attributes

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

Development PerspectiveThis position is explicitly intended as a development role. Through education, experience, and internal training, the job holder should become qualified in the medium to long term to assume the following regulatory functions: