Junior Regulatory Affairs Manager | Biologe (m/w/d)
EvivaMed Handelsgesellschaft mbH
Job Summary
This role involves joining a medical technology wholesaler, part of the ASKER Healthcare Group, focusing on regulatory affairs and quality management for medical devices and IVDs. The Junior Regulatory Affairs Manager will primarily be responsible for ensuring compliance by creating and reviewing accompanying information for products, managing article data (creation, maintenance, and release), and actively contributing to the maintenance and development of Quality Management (QM) systems, ideally aligning with ISO 13485 standards. Day-to-day responsibilities also include coordinating, consulting, and training specialist departments on QM documentation, managing CAPA/change processes, and assisting with the planning and follow-up of internal and external audits. Candidates should possess a degree in natural sciences or equivalent experience, coupled with strong organizational, communication, and teamwork abilities, seeking a stable, international, part-time (30 hours/week) role in a growing industry.
Required Skills
Education
Natural science degree or equivalent qualification
Experience
- Completed natural science degree or equivalent qualification
- Initial experience in Regulatory and Quality, preferably in medical technology or pharmaceuticals
- Professional experience in Quality Management (ideally ISO 13485)
Languages
Additional
- Part-time employment (30 hours per week); Requirement for a well-structured, reliable, and independent working style.