Regulatory Analyst

Job Description

2+ years of experience in medical device regulatory affairs EU MDR, US FDA 510(k) and closely working R&D, Quality organizations. Experience creating Technical Documentation and 510(k) preparation and receiving submission approval (EU, US, Canada 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.) Personality Characteristics Be able to handle ad-hoc changes in priority/planning and independently. Be able to think from customer expectation perspective Be able to work in different teams simultaneously Communicative & disciplined team worker