Regulatory Affairs Specialist

Job Description

Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device regulatory affairs EU MDR, US FDA 510(k) and closely working R&D, Quality organizations. Strong proven experience creating Technical Documentation and 510(k) preparation and receiving submission approval (EU, Canada, US, etc.). Expertise in interpreting and implementing various medical device standards and guidance's, such as IEC 60601-1, ISO 14971-1, IEC 62366-1, ISO10993-1, and MEDDEV 2.7/4. Experience with systems for quality management, product development, and follow-up of procedures is an advantage. Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.)