Senior Quality & Regulatory Specialist – Transform ADHD Care
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.
Apply today—tomorrow might be too late!
- Team
- Quality Assurance and Regulatory Affairs
- Locations
- Stockholm
- Remote status
- Hybrid
Stockholm
Workplace & Culture
We
are humbled to know our innovations make a positive impact in the future of
ADHD management.
Our people are motivated, not only by the desire for success, but also the difference we can make to creating a better healthcare system
Our passion lies in helping to improve the outcomes for those with ADHD; through better diagnosis, better treatment monitoring and better treatment evaluation.
Additionally, we are building a community to offer support to both clinicians and patients, to share best practice and share real-world experience of living with and managing ADHD.
About Qbtech
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.