RA Specialist

Unity Partners exclusively on behalf of our MedTech partner

We arecurrently looking for a Regulatory Affairs Specialist to join a fast-growing and internationally active MedTech company committed to innovation, quality, and patient impact. In this role, you will play a key part in ensuring global compliance and maintaining product registrations for cutting-edge medical devices that directly improve lives around the world.

Key Responsibilities:

·      Manage and maintain global product registration files.

·      Prepare, submit, and update regulatory documentation for international markets.

·      Monitor changes in relevant regulations and legislation to ensure compliance.

·      Provide regulatory guidance to internal stakeholders across departments including Quality, Clinical, R&D, and Engineering.

·      Identify opportunities to improve regulatory processes and drive implementation.

Your Profile:

·      Bachelor’s or Master’s degree in Biomedical Engineering, Chemical Engineering, or a related technical field.

·      Minimum of 3 years’ experience in Regulatory Affairs within the medical deviceindustry.

·      Strong knowledge of international regulatory frameworks.

·      Excellent written and verbal communication skills in English.

·      Highly detail-oriented with strong organizational skills and a proactive mindset.

Organization & Offer:
You will join an international and sustainability-driven organization that values personal growth, strong team spirit, and meaningful impact in healthcare. In return, you’ll benefit from extensive learning and development opportunities, a flexible hybrid working model with 30 vacation days (plus the option to purchase more), and a vitality-focused culture that includes freshdaily snacks and access to wellness programs through the internal Vitality Club. The compensation package features a guaranteed 4% vitality bonus and up to 6% based on collective sales performance, along with an attractive pensionplan requiring only a 1.5% employee contribution. A vibrant social culture is fostered through regular team events, drinks, and gatherings organized by an active employee association.

INTERESTED?
For more information or to apply directly, please contact Christian Steenkamp at +31 (0) 20 8938 606 or via email at christian@unitypartners.nl

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