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Regulatory Affairs Manager

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26 OCT '23: Are you interested in joining a privately held medical device firm located in Utrecht, The Netherlands, dedicated to delivering innovative bioresorbable medical solutions that prioritise safety, efficacy, and cost-effectiveness for their intended applications? Do you have experience with MDD and/or MDR, market access strategies in the EU and regulatory documents submission to health authorities? If so, we invite you to apply!


Medical Devices


Utrecht - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

For our client we are in search of a dedicated and proactive Regulatory Affairs Manager to spearhead the regulatory initiatives. This role is integral to ensuring that the products under Class III, adhere to the required regulatory standards, with a special emphasis on the Medical Device Regulation (MDR). The candidate will possess an in-depth grasp of the intricate regulatory frameworks in various geographies, with a specific focus on the EU although familiarity with the US FDA regulations is also desirable.

QTC logo icon what's needed

What you bring

Key Responsibilities:
  • ​​​​​​​Lead the preparation and submission of regulatory documents and applications to health authorities, ensuring compliance with the MDR and other relevant standards;
  • Monitor market trends concerning EU MDR and US regulatory landscapes;
  • Collaborate closely with R&D, Quality Assurance, and Marketing teams to ensure that all products fulfil the necessary regulatory prerequisites;
  • Offer expertise on regulatory strategy, paving the way for streamlined product development and commercialization;
  • Spearhead regulatory inspections, audits, and reviews;
  • Regularly assess and refine internal processes to bolster efficiency and compliance;
  • Impart training and mentorship to junior staff members on regulatory intricacies;
  • Lead initiatives related to market access both in the EU and on an international scale.

QTC logo icon What we offer

What's in it for you

Minimum Qualifications:
  • Bachelor's degree in a related field (e.g., Life Sciences, Biomedical Engineering, Regulatory Affairs);
  • 3-5 years of relevant experience in regulatory affairs within the medical device sector, with a preference for those familiar with Class III devices;
  • Comprehensive understanding of the Medical Device Regulation (MDR);
  • Robust organisational, analytical, and project management prowess;
  • Fluent proficiency in English;
  • Demonstrable ability to excel in a high-velocity, deadline-centric environment;
  • Direct experience liaising with regulatory agencies like the FDA or EMA;
  • Experience in implantable, injectable materials, or similar domains is an added advantage.

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