Introduction

Do you want to play a vital role in bringing safe and effective medical innovations to patients worldwide? In this role, you are responsible for assessing risks and benefits of medical products to ensure reliability and safety. Your expertise directly impacts people's lives and contributes to groundbreaking healthcare solutions. This is your chance to make real impact.

What are you going to do

What will you do?

  • Perform benefit-risk analyses and contribute to risk management throughout the full product lifecycle.
  • Collect, assess, and analyze clinical data related to medical devices.
  • Prepare clinical documentation, including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) Reports.
  • Collaborate with internal and external stakeholders to ensure accurate and complete analysis of clinical evidence.
  • Support clinical trials and product approvals in the EU, US, and other markets.
  • Lead clinical risk assessments from concept to market introduction.
  • Optimize processes, workflows, and SOPs within the Clinical Development department.

Essential skills and knowledge 

You are detail-oriented, analytically strong, and confident navigating complex regulatory environments. You collaborate easily across disciplines and communicate effectively with diverse stakeholders. In addition, you have:

  • A Master's or PhD degree in Biomedical Sciences or another health-related field.
  • At least 3-5 years of experience in the medical device or pharmaceutical industry.
  • Expertise in benefit-risk analysis and clinical risk management.
  • Experience with vigilance reporting and/or harm reviews.
  • Strong background in medical writing, systematic reviews, and MDR-compliant CERs and PMCFs.
  • Solid knowledge of GCP, ICH guidelines, ISO14155, FDA, and EU regulations.
  • Experience with clinical investigation design, biostatistics, and research methodology.
  • Professional fluency in English (written and spoken).

What we offer

At Brunel, you will work on innovative projects in medical technology from one of the locations in Drachten or Eindhoven. You can count on:

  • A gross monthly salary between €4000 and €5000 (excl. 8% holiday allowance), depending on your experience.
  • 26 vacation days with the possibility to expand.
  • Hybrid working options with flexibility to work from home.
  • Extensive training and career development opportunities through the Brunel Academy.
  • A solid pension plan and collective health insurance.
  • Discounts on gyms, cultural activities, and vitality programs.

About Brunel

Brunel offers professionals an exciting career in an international environment with an open and professional culture. You will have the freedom to develop your expertise, bring your ideas to life, and grow in a results-driven yet supportive workplace. With excellent primary and secondary employment conditions and countless training opportunities through the Brunel Academy, you are guaranteed a career full of growth and opportunities.

Closing: November 02, 2025

Do you have any questions about this vacancy?

Vacancy reference: TR-265945

BvdA

Corporate recruiter

Bo van den Akker

+31 6 23938013

Contact