Quality Assurance and Regulatory Affairs Manager – Northern Europe

Competitive

Our client is a leader in the IVD and medical device industry and as a result of consistent growth the business is looking for a Quality Assurance and Regulatory Affairs Manager to form part of their existing successful team.

Do you have at least 3 years’ experience of managing a team? Would you love the opportunity to join one of the leading multinational companies in the IVD industry?

Our client is a leader in the IVD and medical device industry and as a result of consistent growth the business is looking for a Quality Assurance and Regulatory Affairs Manager to form part of their existing successful team. This is a fantastic opportunity to join a company full of talented and passionate people where everyone’s input is valued and your role will help drive this business forward.

What does the role involve?

You will be responsible for finding and delivering pragmatic solutions. We need an experienced individual who can take responsibility for ensuring conformity of regulatory and strategy. The role also involves being in charge of 2 QRC specialists, supporting commercial business and maintenance of tender submissions and customer contracts. You will be managing and improving the quality of management system and conducts audits and you will also lead the EMEA QRC for various target markets.

What are we looking for?

  • Diploma or PHD in Chemistry, biochemistry, biology, pharmacy or related
  • Experiences in Quality Management and regulatory Affairs
  • 5+ years of experiences in Medical Device
  • Business fluent in German and English
  • Technical degree, diploma or PhD in chemistry, biochemistry, biology, pharmacy, engineering or related.
  • Certificate or Experience in Quality Management or Regulatory Affairs preferred.
  • At least 6 years of experience in regulated industry (Medical Device, IVD or drugs).
  • Advanced knowledge of global regulatory and quality system requirements (e. g. IVDD, ISO Standards, Risk Management, Quality System Standards).
  • At least 3 years of leadership experience (hierarchical or functional).
  • Advanced communication and organization skills.
  • Business-fluent language skills in French or Italian as nice to have

If you think this sounds like a great opportunity for you, please get in touch with your cv.

 

To apply for this job email your details to spellegrino@inveniaresourcing.com.