Medical Device Regulatory Specialist

6 hours ago


Stockholm, Stockholm, Sweden QBtech AB Full time

Transforming Healthcare

Qbtech is the global market leader in professional ADHD tests, providing CE marked and FDA cleared tests for use in assessing and treating ADHD. Our vision is to empower clinical and financial decision-makers with leading objective tests, products, and services that improve outcomes and support patients.

We are looking for a Medical Device Regulatory Specialist to join our global team.

About the Role

The successful candidate will be responsible for ensuring our Quality Management System (QMS) remains updated and compliant with relevant legislation(s). They will also support Qbtech in fulfilling regulatory requirements when medical devices are designed, developed, manufactured, and distributed to target markets.

Essential Duties and Responsibilities

  • Coordinate/act as host during inspections and audits by notified bodies and authorities.
  • Provide expert advice on Qbtech Management Systems, including ISO 13485, 21 CFR 820, ISO 27001, EU-MDR 2017/745, and country-specific medical device legislations.
  • Be a key member of the Product Development Team, ensuring compliance with Medical Device legislations and Qbtech QMS requirements.
  • Perform internal and supplier audits.
  • Ensure document and record control.
  • Responsible for CAPA, Change Control, Complaints, and Non-Conformances.
  • Perform training in quality and regulatory matters.

Requirements

  • Adequate scientific education, BSc or higher.
  • Experienced from previous work with Medical Device Software Development.
  • Verbal and written English proficiency.
  • Able to pass a background check.


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