Senior Quality & Regulatory Specialist – Transform ADHD Care
Posted on March 23, 2026 (2 months ago)
This job post is archived - the company is no longer hiring for this position.
Check out other job posts of this company here!Join Qbtech and Transform Healthcare
Would you like to help transform healthcare? Qbtech is the global market leader in professional ADHD tests, CE marked and FDA cleared, supporting assessment and treatment for people aged 6–60. Our vision is to provide a complete ecosystem of tests, products, and services that empowers clinicians and to improve outcomes and help patients better understand their symptoms and treatment. With offices in Stockholm, London, and Houston, and operations in 14 countries, Qbtech is expanding its services, products, and technologies worldwide.
About the Role
We are looking for a Senior Quality & Regulatory Systems Specialist to take ownership of quality and regulatory compliance. This is your chance to influence every stage of the medical device software lifecycle—from design to release and beyond.
Your Mission
Work cross-functionally to align quality and regulatory requirements throughout the medical device software lifecycle, including product initiatives, design changes, releases, and maintenance activities, in accordance with the Quality management system (including the creation, maintenance, review, and/or approval of Medical Device Files/Technical Documentation).
Support the qualification and validation of digital tools and systems used within the QMS and software development environment, ensuring compliance with the quality management system.
Lead the implementation, maintenance, and user training of Qbtech’s eQMS system.
Support the development and implementation of regulatory strategies, including submissions, approvals, significant and non-significant change notifications, and new market entries, in collaboration with cross-functional stakeholders.
Perform internal audits and follow up on proposed improvements as per defined procedures.
Support companywide and employee specific training initiatives to promote quality and regulatory compliance with applicable regulations, standards, and internal procedures.
Act as deputy to the Project Quality & Regulatory Manager and/or System Quality & Regulatory Manager at head office.
Who You Are
A proactive, detail-oriented professional with a proven track record in SaMD quality and regulatory excellence. You have:
- 7+ years in regulatory/quality roles for medical device software
- Expertise in IEC 62304, ISO 13485, ISO 14971, EU MDR, FDA QMSR
- Knowledge of software development, cybersecurity, and medical software architecture
- Experience with international regulatory submissions
- Strong problem-solving, communication, and leadership skills
Why Qbtech?
Make a real impact—help people understand ADHD while transforming healthcare globally. Join an international team of experts, lead first- and best-in-class products, and grow your skills in a company that invests in you. Hybrid work, minimum 3 days/week in Stockholm.
How to apply
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Additional information
If you have questions about the role, you can use the contact options on the Qbtech careers site. Applications are processed via the online application form.