Regulatory Compliance Manager

17 hours ago


Stockholm, Stockholm, Sweden QBtech AB Full time

Job Description

QBtech AB is seeking a qualified System Quality Regulatory Manager to oversee the maintenance and implementation of our Quality Management System (QMS). The ideal candidate will possess a strong background in quality management systems, specifically in the medical device industry, and expertise in regulations such as ISO 13485, 21 CFR 820, and EU-MDR 2017/745.

Main Responsibilities

  1. Maintain the QMS in compliance with relevant legislation and ensure its correct implementation at our headquarters and subsidiaries.
  2. Act as the host during inspections and audits by notified bodies and authorities.
  3. Provide expert advice on Qbtech Management Systems and support the organization in fulfilling regulatory requirements.
  4. Collaborate with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.

Essential Qualifications

  • Adequate scientific education, BSc or higher.
  • Verbal and written English proficiency.
  • Ability to pass a background check.

What We Offer

At QBtech AB, you will contribute to the development of innovative products that improve patient outcomes. You will work in an international environment and collaborate with experienced professionals who share your passion for quality and excellence. We offer opportunities for growth, education, and certifications in relevant fields, as well as a flexible remote work arrangement.



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