System Quality Regulatory Manager

3 weeks ago

Stockholm, Stockholm, Sweden QBtech AB Full time

Would you like to take part in transforming healthcare? Qbtech is the global market leader in professional ADHD tests, providing tests that are both CE marked and FDA cleared for use as an aid in the assessment and treatment evaluation of ADHD for people age 6-60. Our vision is to transform healthcare by providing a complete system of leading objective tests, products and services that empowers clinical and financial decision-makers to improve outcomes and support patients to better understand their symptoms and treatment.

Qbtech is present in 14 countries with offices in Stockholm, London and Houston. Over the next years, Qbtech will make significant investments into new products, technologies and people to further strengthen their services and product offerings with the aim of building an ecosystem with solutions for providers, clinicians and patients.

Now we are looking for a System Quality Regulatory Manager (SQR Manager) to join our global team

About the role

The SQR Manager will keep the Quality Management System (QMS) updated and in compliance with relevant legislation(s) and ensure correct implementation of the QMS at Qbtech's headquarters and the subsidiaries in Europe and the USA. The SQR Manager will also support Qbtech to fulfill the regulatory requirements when medical devices are intended to be designed, developed, manufactured, and distributed to the target market(s).

Essential Duties and Responsibilities

  • Coordinate/act as the host when the organization is subject to inspections and/or audits by notified bodies and authorities.
  • Have a great know-how in Qbtech Management Systems in line with ISO 13485, 21 CFR 820, ISO 27001, EU-MDR 2017/745, and other country-specific medical device legislations, to provide support and advice to the organization.
  • Be a vital member of the Product Development Team to ensure 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 QARA Manager in headquarters and/or QARA Manager at Qbtech US site.

Who are you?

  • Experienced from previous work with Medical Device Software Development.
  • Adequate scientific education, BSc or higher.
  • Experienced from previous work 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.

We are looking for someone who has

  • 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 can Qbtech offer you?

At Qbtech you will have the opportunity to work with something meaningful that helps people understand ADHD while transforming healthcare. You will work in an international environment together with some of the leading experts in the world. You will lead the development of best-in-class as well as first-in-class products and services – globally. There are plenty of opportunities to learn and grow and to expand into other technologies within the company. Qbtech also offers education and certifications in fields that are relevant to the technology used within the company.

This role has a hybrid remote setting; at least 3 days in the Stockholm office per week. Some domestic and international travel is required.

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