Product Review Specialist

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Product Review Specialist - Active Devices

We are seeking a Product Review Specialist to join our team.

This role will allow you to make a significant impact in the field of certification.

As a member of our Medical Device team, you will manage a small team of globally based Product Assessors and work in the exciting field of Active Medical Devices.

Your responsibilities will include:

  • Supporting and guiding your team of talented Product Assessors
  • Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards
  • Collaborating with cross-functional teams to increase efficiency and quality
  • Monitoring the team's technical competence, KPIs, and wellbeing, providing feedback and support
  • Recruitment activities, including reviewing CVs, interviewing, and onboarding new starters
  • Developing and delivering training sessions internally and externally as needed
  • Assisting with technical queries and sales-related activities in the Active Medical Devices field

Required Skills and Qualifications

Please submit an English CV with your application.

To qualify, you should have prior experience as a Product Assessor/Specialist/Technical File Reviewer within a Notified Body for active devices, reviewing against MDD and/or MDR standards.

Additional requirements:

  • At least four years of professional experience in healthcare products or related fields such as design, manufacturing, auditing, or research, with two years in device design, manufacture, testing, or scientific assessment
  • Knowledge of Active Medical Devices (monitoring, therapeutic, radiation, software devices, etc.) through design, manufacturing, or testing
  • Thorough understanding of standards like EN 60601, EN 62304, EN 62366
  • Strong written English skills (for report review and communication)
  • Knowledge of relevant Technical File codes as per EU regulations (desirable)

Benefits

Enjoy flexible scheduling and remote work options

Access continuous learning through internal training programs

Work in a multicultural environment with colleagues worldwide

Benefit from comprehensive employee benefits

At our company, we foster an open, friendly, and supportive culture emphasizing teamwork, diversity, and personal growth.

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