Regulatory Affairs and Quality Manager

11 hours ago


Stockholm, Stockholm, Sweden QBtech AB Full time

Join Our Team

Qbtech AB is seeking a talented System Quality and Compliance Expert to help us drive innovation in professional ADHD tests.

About the Role

The chosen candidate will play a pivotal role in maintaining our Quality Management System (QMS) in line with relevant legislation(s). They will also provide essential support to Qbtech in meeting regulatory requirements for medical devices.

Main Responsibilities

  • Support the organization in preparation for 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.
  • Work closely with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
  • Conduct internal and supplier audits.
  • Manage document and record control.
  • Responsible for CAPA, Change Control, Complaints, and Non-Conformances.

Requirements

  • Bachelor's degree or higher in a relevant field.
  • Background in Medical Device Software Development.
  • Strong verbal and written communication skills in English.
  • Able to pass a background check.


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