Regulatory Affairs Officer

JOB PROFILE

Role description
As an RA Officer, you will take on an administrative role within the Regulatory Affairs team, supporting the RA managers in various critical processes, ensuring compliance and smooth operations across multiple regulatory domains.

Primary Responsibilities and Tasks
-Master Text support

  • Act as the primary point of contact for the Regulatory Affairs teams of Oystershell’s customers during the Master Text process.
  • Reviewing and checking labelling text for medical devices, biocides, cosmetics and food supplements in the Master Text process

-Vigilance support

  • Support the RA and Vigilance Manager in handling incidents reported to the vigilance team.
  • Record incidents in the document management system and organize files on the server.
  • Prepare notifications for submission to the Notified Body and/or Health Authority.

-GS1 and EUDAMED support

  • Collaborate with the RA and Vigilance Manager to input and maintain data in the GS1 and EUDAMED systems.

-Territorial registrations support

  • Assist the RA and Vigilance Manager in collecting required information for territorial registrations.
  • Request Free Sales Certificates from FAGG and provide support for the legalization and notarization of legal documents. 

-Update Declarations of Conformity 

  • Draft and update Declarations of Conformity annually and on demand, ensuring they are accurate and meet requirements for Notified Bodies and Competent Authorities. 

-Mail management of the regulatory inbox

JOB REQUIREMENTS

Education & experience

  • Bachelor or Master’s degree preferable in a life science discipline.
  • Regulatory background is a plus.

Technical skills

  • Excellent knowledge of English. Knowledge of Dutch is a plus.
  • Proficiency in Office application (Excel, Word) essential, experience with an ERP package is a plus.
  • Experience with Quality Management System.
  • Knowledge of the ISO13485:2016 is required (training will be needed if requirement not met).

Competencies & expected professional attitude

  • Accurate, deadline-oriented, efficient, flexible, multi-functional.
  • Resilient under stress and adaptable to challenges.
  • Possess a mature, positive personality with strong organizational and analytical skills.
  • Demonstrate a can do & hands-on mentality, with a customer- and solution-oriented mindset.
  • Exhibit a learning attitude: curious, interested and eager to grow.
  • Diplomatic, goal-driven and an excellent team player.
  • Strong communication skills to foster optimal collaboration within the company and across departments.
  • It is our expectation that you live up to our quality standards as described in the quality policy. We expect you to take the necessary actions to comply with the quality objectives.

Are you ready for the next step in your career?
Send your CV and motivation letter to hr@oystershell.be. Response and confidentiality are guaranteed.