Regulatory Affairs Officer

Regulatory Affairs Officer - Rotterdam

  • Leading, coordinating, implementing and monitoring registration processes;
  • Check and approve qualification files to meet requirements for admission in a specific market;
  • Continuously monitoring and analyzing current medical standards and international regulations and translating them into qualifications required for products;
  • Advise and assist R&D with product development and product changes according to the applicable standards and registration requirements;
  • Advise and support departments about admission requirements, quality and safety standards and regulatory requirements that apply within different countries;
  • Capture registration requirements as a critical part of the technical documentation in collaboration with R&D and Marketing and Sales;
  • Support external audits, track GMP processes and systems;
  • Maintaining good relations with external Regulatory Affairs authorities, notified Bodies and the global network of distributors.

Job requirements

  • Bachelor or University degree medical / technical;
  • Minimum of 2 years experience in an RA position in medical devices;
  • Current knowledge of international law and regulations for medical devices;
  • Pro-active personality who acts convincingly as responsible for the entire registration process;
  • Excellent Dutch and English language skills both verbal and in writing.

Job offer

Our client offers a challenging position in an international growing company offering an excellent remuneration package including

  • 27 holiday days
  • 13 extra leave days
  • 8% holiday pay
  • 13th month bonus
  • Travel allowance
  • Collective health insurance
  • Reimbursement of pension contributions

More information

Esron Loupatty
T. +31 76 531 7729

Locatie

Rotterdam area

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