Quality Assurance and Regulatory Affairs Specialist

5 days ago


Stockholm, Stockholm, Sweden QBtech AB Full time

About the Company

Qbtech AB is a global market leader in professional ADHD tests, providing CE marked and FDA cleared tests that aid in the assessment and treatment evaluation of ADHD for individuals aged 6-60. The company aims to transform healthcare by offering a comprehensive system of leading objective tests, products, and services empowering clinical and financial decision-makers to improve outcomes and support patients in understanding their symptoms and treatment.

The company has offices in Stockholm, London, and Houston and plans to invest significantly in new products, technologies, and people over the next years to strengthen its services and product offerings, ultimately building an ecosystem with solutions for providers, clinicians, and patients.

About the Role

We are seeking a System Quality Regulatory Manager (SQR Manager) to join our global team. This role is crucial in ensuring the Quality Management System (QMS) remains updated and compliant with relevant legislation and ensures the correct implementation of the QMS at Qbtech's headquarters and subsidiaries in Europe and the USA.

The SQR Manager will also support Qbtech in fulfilling regulatory requirements when designing, developing, manufacturing, and distributing medical devices to target markets.

Key Responsibilities
  • Coordinate and act as the host during inspections and/or audits by notified bodies and authorities.
  • Have extensive knowledge of Qbtech Management Systems aligned with ISO 13485, 21 CFR 820, ISO 27001, EU-MDR 2017/745, and other country-specific medical device legislations, providing support and advice to the organization.
  • Be a vital member of the Product Development Team, ensuring compliance with medical device legislations and Qbtech QMS requirements when designing, developing, and maintaining medical devices.
  • 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.
  • Act as the deputy to the QARA Manager in headquarters and/or QARA Manager at Qbtech US site.

Requirements

  • Previous experience working with Medical Device Software Development.
  • Adequate scientific education, BSc or higher.
  • Experience working with Quality Management in accordance with ISO 13485 and US 21 CFR Part 820.
  • Verbal and written English proficiency.
  • Able to pass a background check.

Preferred Qualifications

  • Knowledge of Regulation (EU) 2017/745, US 21 CFR Part 820, ISO 13485:2016, ISO 27001.
  • Knowledge of Medical Device Software Development.
  • Great communication skills.
  • Scientific skills.
  • Ability for sustained accuracy.
  • High ability to interact with internal and external stakeholders.

What We Offer

You will have the opportunity to work on meaningful projects that help people understand ADHD while transforming healthcare. You will work in an international environment with some of the leading experts in the world. There are opportunities to learn and grow and expand into other technologies within the company. Qbtech also offers education and certifications in fields relevant to the technology used within the company.


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