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Regulatory Affairs Manager
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
Quality/RA
Utrecht - Netherlands
40 hours per week
Get to know
Your consultant
About your role
This is how you will make the difference
what's needed
What you bring
- 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.
What we offer
What's in it for you
- 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.
Send your application