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Regulatory Affairs Specialist

Regulatory Affairs Specialist

LocationArnhem , Netherlands
Business SectorMedical Device
Contact nameAimee Brenner
Contact email
Job ref25040
Published1 day ago

Job Description:
Are you an experienced Regulatory Affairs professional with a strong background in medical devices? Would you like to contribute to a fast-growing, international organization dedicated to improving patient outcomes through innovation? We are currently supporting an innovative MedTech manufacturer in their search for a proactive Regulatory Affairs Specialist. In this role, you will take ownership of global product registrations and ensure ongoing compliance with international medical device regulations. You’ll collaborate with cross-functional teams across Quality, Clinical, R&D, and Engineering to support breakthrough technologies.

Company Description:
Our client is a medium-sized, sustainability-driven medical device manufacturer based in the eastern region of the Netherlands. Known for its commitment to patient impact and innovation, this company operates globally with a growing footprint across multiple regulated markets. The culture is entrepreneurial and collaborative, with strong emphasis on professional development, well-being, and long-term employee engagement.

Essential Requirements:

  • Minimum of 3 years of experience in Regulatory Affairs within the medical device industry

  • BSc or MSc in Biomedical Engineering, Chemical Engineering, or a related technical field

  • Proven ability to maintain and manage international product registration files

  • Strong command of English, both written and spoken

  • Detail-oriented with excellent multitasking and project management skills

  • Communicative and proactive mindset with a structured and energetic approach

Desirable Requirements:

  • Cross-functional experience with Quality, R&D, or Clinical departments

  • Knowledge of evolving international regulatory landscapes and upcoming compliance trends

  • Process improvement experience within regulatory systems or documentation workflows

Additional Insights:
The position is full-time and located in the eastern Netherlands, with hybrid working flexibility. The organization offers robust development opportunities, 30+ vacation days and great additional benefits.