Hybrid Regulatory Affairs Officer, Medical Device

Posted last month

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About the role

  • Manage regulatory submissions for medical devices in accordance with U.S. FDA and EU MDR/IVDR requirements
  • Review and assess technical documentation for compliance with regulations, including risk assessments and clinical evaluations
  • Prepare and maintain regulatory files and submissions, ensuring accuracy and completeness
  • Collaborate with cross-functional teams to ensure timely product launches and compliance with post-market surveillance activities
  • Stay updated on regulatory changes and advise the organization on potential impacts on products and processes

Requirements

  • Minimum of 3-5 years in regulatory affairs, specifically related to medical devices
  • Proven experience with regulatory submissions
  • In-depth understanding of EU and U.S. medical device regulations (EU MDR/IVDR and U.S. FDA)
  • Excellent analytical and communication skills
  • Strong attention to detail
  • Degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field
  • Fluency in English and French; additional languages are a plus

Benefits

  • We are a young, ambitious health company representing 900 Excelyates and aiming to become Europe’s leading mid-size CRO
  • One-stop provider service model offering full-service, functional service provider (FSP), and consulting—enabling diverse project experience
  • Opportunity to work alongside preeminent experts and evolve scientific, operational, and human knowledge
  • Supportive environment that values natural talents, pushes boundaries with audacity, and nurtures your potential

Job title

Regulatory Affairs Officer, Medical Device

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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