MSI Pharma are acting as a recruitment partner for a leading and fast growing Notified Body for the Medical Device Industry. Therefore we are constantly looking for medical auditors or technical file reviewers. Dealing with cutting-edge medical innovations, the notified body provides their clients with worldwide market access through executing conformity assessments for high risk devices with offices in Europe, USA and Japan.

Responsibilities

After an extensive internal training program, you will:

• Execute audits and processes independently;
• Are responsible for the assessment of technical files and the auditing of quality systems of your costumers (from high innovative start-ups to large multinationals, both national and international);
• Act as a linking pin (account manager) and maintain frequent contact with your costumers, colleagues, external experts like physicians, contractors and authorities;
• Will have the opportunity to represent company at conferences;
• Will travel within and outside Europe, approximately 40% of the time.

What we expect from you

• A (Bachelor or) University level degree in life- and/or engineering sciences is a must;
• A minimum of 4 years of full time work experience in medical device related industry, including at least 2 years in R&D (or QA/RA);
• Experienced in at least one of the following devices categories and areas of expertise: Orthopaedic devices, Active medical devices, Active implantable medical devices, Soft tissue implant, Cardiovascular devices, Drug device combinations or Animal tissue;
• Experienced with quality management systems and relevant laws and regulations, at least CE;
• Project management and auditing experience is considered an advantage;
• English language skills are a must