Regulatory Affairs Officer

• 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.

• 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.

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