Head of Regulatory Affairs

The Surgical Company PTM is looking for a Head of Regulatory Affairs

Offer

  • a challenging position with plenty of room for initiative
  • dynamic and ambitious working environment at a medium sized health company in the medical devices industry
  • innovative, lively and ambitious environment with great opportunities


Position

As Head of Regulatory Affairs (RA) you are responsible for managing and developing the four global RA team members, of which three are located in The Netherlands and one in France. Besides this you will be responsible for development and continuous improvement of Regulatory Compliance Framework, policies, procedures, work instructions and guidance to support RA and develop personnel in assuring Regulatory Compliance in a lean and effective way. You will conduct trainings and/or communicate appropriate materials, in order to enhance the development team its knowledge of working in a regulated environment. You will manage the regulatory budget and ‘own’ the RA strategy. You will also develop, supervise, and manage international regulatory strategies and activities in alignment with other RA functions, and provide leadership for submission roll out and maintenance. Furthermore, you are responsible for providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities within the region. As Head of RA, you will act as a business partner to the company’s development team, regional organizations and supply chain teams. You will manage the completion of the relevant documentation to allow timely submissions to regulatory agencies for the assigned products/countries. Besides this, you will participate in business meetings with existing and prospective external partners, ensure that Change Control Boards consider the regulatory implications for respective regions, and assure that proposed labelling, packaging, advertising and promotional materials are reviewed, evaluated and approved to be in conformance to regulations before they are published.


Profile

  • master’s degree preferred in Engineering, Pharmacy, Chemistry or other science discipline
  • minimum of 5 years working experience in regulatory; preferably with product development in the medical device industry
  • proven leadership skills with a strong quality vision and able to reduce cost of non-quality
  • experience with applicable standards, including ISO 13485 certifications by notified bodies, ISO 14971, EN 45502 and MDD/ AIMDD, as well as 21 CFR part 820; SOR98-282, TGA, IEC 60601-1 series, ISO 10993 series, ISO 14155 and ISO 1135 are recommended
  • strong stakeholder management and influencing skills; team builder with strong people management skills
  • experience in global regulatory affairs, and clinical planning and execution are a preference
  • open to travel to France (6-10 times a year)
  • strong written and oral communication skills in both English and Dutch


Interested? 

Please send your resume and motivation letter to 
After a pre-selection process, you can receive an invite for (face-to-face) business interviews. 
 

* Please note that acquisition is not appreciated *