Common questions about eu mdr jobs careers in the medical device industry. Jobs are aggregated daily from multiple sources and filtered to this category.
- What does an EU MDR specialist do?
- An EU MDR specialist ensures medical devices comply with the European Medical Device Regulation (2017/745). Responsibilities include: Technical Documentation - Preparing and maintaining technical files per Annex II/III, Clinical Evaluation - Managing clinical evaluation reports (CERs) and PMCF plans, Notified Body Liaison - Coordinating conformity assessments and audits, UDI/EUDAMED - Managing European database registrations, Post-Market Surveillance - Implementing PMS systems and vigilance reporting.
- What qualifications are needed for EU MDR jobs?
- EU MDR positions typically require: Education: Bachelor's or Master's in life sciences, biomedical engineering, or regulatory sciences. Experience: 3-5 years minimum in medical device regulatory affairs. Knowledge: Deep understanding of MDR 2017/745, familiarity with IVDR, ISO 13485, ISO 14971. Skills: Technical writing, clinical evaluation expertise, project management. Language: English required, additional European languages (German, French) valuable. RAC-EU certification is highly desirable.
- Why is EU MDR expertise in such high demand?
- EU MDR demand is driven by several factors: Transition deadlines - Legacy devices must transition by 2027-2028, creating urgency. Complexity - MDR requirements are significantly more stringent than MDD. Clinical evidence - New CER requirements need specialized expertise. Notified Body capacity - Limited NB availability increases need for well-prepared submissions. Global impact - Many companies use EU MDR as basis for other markets. This has created a significant talent shortage and premium salaries.
