Company

Our client is an international and entrepreneurial family owned business operating in the health sector. Our client is currently based in several European countries. They are currently looking for a Regulatory Affairs Manager, who will be in charge of the regulatory affairs processes and report directly to the CEO.

Position

  • You will be responsible for product registration submissions of products, renewal approvals, product technical dossiers and other regulatory documents;
  • You will coordinate projects and assure that all appropriate actions are initiated in time and in budget;
  • You will keep abreast of international legislation, guidelines and customer practices by liaising with official institutions;
  • You will identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated;
  • You will serve as regulatory contact person for distributors and authorities;
  • You will be involved in the check of all communicated information as for example packaging material and leaflets;
  • You will lead a small international team, conduct appraisals and coordinate projects in the team;

Profile

  • Scientific degree with at least 5 years’ experience in international medical devices regulatory affairs;
  • Managerial experience;
  • Experience with the guidelines for clinical evaluation reports and literature search reports;
  • Knowledge of regulatory affairs related to FDA and other non-EU regulations is an asset;
  • Project management knowledge is an asset;
  • Familiar with MS Office and database applications;
  • Fluency in English is mandatory, German would be an asset;
  • Detail-oriented, analytically strong and autonomous.

For more information please contact Nina by phone on +352 26 29 45 23.

THE RECRUITER is a recruitment and executive search company specialised in ICT – Telecoms – Digital – Cleantech – Services & Industry. THE RECRUITER empowers companies in their recruitment and HR projects, trusting that Human Factor, thanks to committed, motivated and implicated people, will bring success and added value in any business. THE RECRUITER defines its core values as: transparency, flexibility, professionalism and commitment. We apply these rules to any HR project we are in charge of.

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