Regulatory Analyst

• 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