Pre Market Quality and Regulatory Specialist (m/f/d)
DedalusBIH - Sarajevo
Posted March 31, 2026
Full Time
About the Company
Dedalus is committed to providing an engaging, rewarding work experience that reflects the passion our employees bring to our mission of helping clinicians and nurses deliver better care to their served communities.
Job Description
Join our team as a Pre-market QARA Specialist and ensure ongoing Quality and Regulatory compliance of products and services. You will drive and manage the implementation of the Dedalus Healthcare Quality Management System and provide guidance and define regulatory plans and strategies.
Requirements
- Minimum 3-5 years of experience in a regulated industry – preferably medical device, pharmaceutical or related – holding a position in quality management, quality assurance and regulatory affairs, or project management position.
- English (upper intermediate or better)
- Ability to analyse, understand, and interpret regulations and standards for a more general business audience
- Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive, and new Medical Device Regulation MDR and IVDR.
Benefits
- Engaging and rewarding work experience
- Opportunities for learning and innovation
- Diverse and inclusive work environment
