Senior Quality & Regulatory Specialist
Needo Recruitment Sthlm AB · Stockholm · Tills vidare · Deadline 2026-10-31
Qbtech is recruiting a **Senior Quality & Regulatory Specialist** through Needo Recruitment Sthlm AB for a full-time position based in central Stockholm, with a **hybrid schedule of approximately three days per week in the office**. Bridging the QA/RA function and software development teams, the role supports product changes, releases, risk management, and the software lifecycle for medical devices used in ADHD care. Key duties include reviewing technical documentation and Medical Device Files, contributing to regulatory assessments and submissions, assisting with audits and training, implementing and developing the company's eQMS, and validating digital systems. The position requires several years of Quality & Regulatory experience within the medical device industry, specifically involving **software or Software as a Medical Device (SaMD)**. Applicants must demonstrate a solid understanding of software development and technical documentation, fluency in English, good knowledge of IEC 62304 and ISO 13485, risk management experience such as ISO 14971, and familiarity with EU MDR and/or FDA requirements. Beneficial qualifications include experience with eQMS implementation, digital system validation, internal audits, and AI or cybersecurity in medical devices.
Do you have experience in Quality & Regulatory within Software as a Medical Device and enjoy working at the intersection of product development, quality, and regulatory requirements? Are you technically curious and experienced in supporting development teams through complex changes? Then the role as Senior Quality & Regulatory Specialist at Qbtech could be the right opportunity for you!
About Qbtech Qbtech
is an international MedTech company developing technology-based solutions for the assessment and monitoring of ADHD. Founded in 2002, Qbtech operates across several international markets, with offices in Stockholm, London, and Houston. Qbtech’s solutions are used by clinics worldwide, with a mission to contribute to more accessible, efficient, and data-driven ADHD care.
About the role
As Senior Quality & Regulatory Specialist, you will act as an important link between Qbtech’s Product and Software teams and the QA/RA function. You will support Product Owners and development teams in product changes, releases, and design changes, ensuring that quality, risk management, and regulatory requirements are integrated throughout the software lifecycle. The role also includes working with technical documentation, Medical Device Files, regulatory assessments, and market expansion activities. A particular focus will be on the implementation and continuous development of Qbtech’s eQMS, as well as the validation of digital systems and tools.
Your main responsibilities:
- Support Product and Software teams with change management, releases, and risk assessments.
- Ensure Quality and Regulatory requirements are integrated into product development.
- Review and maintain technical documentation and Medical Device Files.
- Contribute to regulatory assessments, submissions, and market expansion activities.
- Implement and further develop Qbtech’s eQMS.
- Support the organisation with risk management, audits, and training.
About you
You have several years of experience within Quality & Regulatory in the Medical Device industry, with clear experience in software or Software as a Medical Device.
You do not need to be a developer or know how to code, but you have a good understanding of software development and are comfortable discussing areas such as the software lifecycle, requirements, verification, risks, and architecture with technical teams.
You are communicative, down-to-earth, and pedagogical, and you enjoy working in an international environment where you can combine specialist expertise with close cross-functional collaboration.
Important qualifications:
- Experience within Quality & Regulatory in Medical Devices and software/SaMD.
- Good knowledge of IEC 62304 and ISO 13485. • Experience in risk management, for example ISO 14971.
- Experience with EU MDR and/or FDA requirements. • Good understanding of software development and technical documentation.
- Fluent English.
Meritorious:
- Experience with eQMS and system validation.
- Experience with AI or cybersecurity within Medical Devices.
- Experience conducting internal audits.
What Qbtech offers
At Qbtech, you will join an international MedTech company where technology, product development, and regulatory affairs come together. The culture is open and non-hierarchical, with short decision-making paths and close collaboration across functions.
Qbtech offers, among other benefits, 30 days of annual leave, a wellness allowance, private healthcare insurance, and a pension scheme corresponding to ITP1.
Other informationStart: As soon as possible or upon agreement.Employment: Full-time.Location: Central Stockholm, hybrid with approximately three days per week in the office.