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Regulatory Affairs Officer

  • Maastricht

  • HBO

  • 25 - 32

The Regulatory Affairs Administrator provides administrative and coordination support for international registration activities. The role focuses on managing regulatory documentation, supporting dossier preparation, liaising with internal stakeholders and external partners, and ensuring compliance with global regulatory requirements.

Wat ga je doen?

Heb jij de ambitie om onze Regulatory Affairs Officer te worden?

  • Coordinate, prepare, and follow up on international registration submissions (finished products and intermediates) through partners acting as Marketing Authorization Holders, ensuring timely submission.
  • Act as a liaison between external partners and internal departments to obtain all required documentation related to product changes and new product launches.
  • Prepare international submission dossiers in collaboration with Regulatory Affairs, Commercial, Quality, R&D, and other relevant functions, ensuring completeness and timeliness.
  • Support communication with international regulatory authorities, including preparing statements and justifications, or directly corresponding when required.
  • Maintain and update regulatory files and databases, ensuring documentation is accurate, complete, well-organized, and properly archived; monitor submission status and follow up as needed.
  • Manage and resolve queries from international regulatory authorities by coordinating and gathering required information from Regulatory Affairs, Commercial, Manufacturing, Quality Assurance, Medical, and other relevant departments.
  • Monitor regulatory developments (e.g., new guidelines, legislative changes) and inform the internal organization about upcoming regulatory changes and their potential impact on international registration dossiers.

Wat krijg je?

  • a contract directly with our client. 
  • responsible and impactful role within an international Regulatory Affairs environment.
  • The opportunity to contribute directly to compliant and successful global product registrations.
  • A professional and innovative working environment within the medical technology sector.
  • Close collaboration with multidisciplinary teams including Regulatory Affairs, Quality, R&D, Commercial, and Manufacturing.
  • Room for personal and professional development within the Regulatory Affairs field.
  • Exposure to international regulations and global market registrations.
  • A collaborative culture with short communication lines and an open, professional atmosphere.
  • Competitive employment conditions in line with your knowledge and experience.
  • The intention to build a long-term working relationship based on performance and mutual fit.

Dit ben jij

Dit zoeken we in onze Regulatory Affairs Officer

Must: 
  • Bachelor’s or Master’s degree in a scientific discipline.
  • 1–3 years of experience in Regulatory Affairs.

Preferred:
  • Knowledge of the clinical application of the products distributed by PMI.

Job-Related / Technical Skills
  • Bachelor’s degree (BSc) or equivalent academic/work experience.
  • Knowledge of and/or experience with process improvement and quality management systems.
  • Familiarity with ISO 13485 and other applicable medical device standards and regulations (e.g., FDA, CFDA, etc.).

Soft Skills
  • Strong analytical skills with a high level of accuracy and a structured working approach.
  • Excellent verbal and written communication skills in both Dutch and English.
  • Ability to influence and engage stakeholders at different levels within the organization.
  • Capable of working independently while also functioning effectively as part of a team.
  • Ability to interpret complex regulatory texts and translate regulatory requirements into practical application.

Languages & IT Competencies
  • Excellent written and verbal communication skills in Dutch and English for both internal and external stakeholders.

Over de werkgever

Our client is a medical technology company specialized in diagnostic imaging.

Interesse?

Ben je geïnteresseerd in de functie van Regulatory Affairs Officer en wil je solliciteren? Klik dan op de ‘solliciteer’ button, wij nemen dan zo spoedig mogelijk contact met jou op om de mogelijkheden te bespreken. Wil je eerst meer weten over de vacature of heb je nog een vraag? Neem dan contact op met Edmee Peters via mail of telefoon.