Quality Management and Regulatory Systems

Quality Management System (QMS) and Regulatory Department Regulatory Affairs Specialist (Medical device technical documentation)

Your responsibilities

Preparation of technical documentation for IVDs & FDA various risk classes.
Post-marketing surveillance activities.
Participating in compliance / QMS audits.
Drafting / updating regulatory processes (procedures & records).
Cooperating with QMS department on daily basis.
Occasionally contacting Notified Bodies.
Preparation of PMPFs.
Coordination of performance evaluations.
Other, as per IVDR & FDA requirements.
Preferable: experience with FDA.

Our requirements

Higher education in biotechnology, life and medical sciences, maths/physics, biomedical engineering, philosophy or a related field.
Documented minimum of 2 years of experience with regulatory compliance based on IVDR and FDA.
Solid knowledge of FDA requirements and related MDCG & IMRDF requirements.
Attention to detail and ability to work independently, set task priorities, and meet deadlines.
Proficiency in English (B2 or above) – note that all procedures and technical documents will be written in English, some team mates also speak English only.
Experience with ISO13485.

This we offer

Join a team of passionate, forward-thinking regulatory professionals dedicated to overcoming challenges and pushing the boundaries of innovation. At our company, you’ll work in an energetic environment where problem-solving is key, and every team member is driven by a shared vision of advancing medical technology. Embrace the opportunity to contribute to groundbreaking projects and make a tangible impact on the future of healthcare.