BD

Regulatory Affairs Specialist – EMEA

BD

full-time

Posted on:

Location Type: Hybrid

Location: Erembodegem • 🇧🇪 Belgium

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Salary

💰 €49,100 - €83,500 per year

Job Level

Mid-LevelSenior

About the role

  • Supporting and executing regulatory activities across multiple projects and Specimen Management product lines
  • Reviewing and approving advertising and promotional materials
  • Managing regulatory and product related documentation
  • Acting as the regulatory point of contact for B2B clients
  • Leading non-product regulatory projects and overseeing label review processes

Requirements

  • Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field (Master’s degree preferred)
  • 3-5 years of experience in regulatory affairs, preferably within the medical device, pharmaceutical, or life sciences industries
  • Strong understanding of EMEA legislation, standards, and regulatory frameworks, particularly for medical devices
  • Proficiency in managing regulatory documentation, labeling requirements
  • Excellent verbal and written communication skills, with fluency in English
Benefits
  • Health insurance
  • Career development opportunities
  • Performance-based bonuses

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory affairsregulatory documentation managementlabeling requirementsEMEA legislationregulatory frameworksmedical devicespharmaceuticalslife sciences
Soft skills
communication skillsverbal communicationwritten communicationclient managementleadership
Certifications
Bachelor’s degreeMaster’s degree