Senior Quality & Regulatory Specialist

Qbtech; København; Remote; DKK 82,000 - 109,000; Full time

Benefits offered by this job

30 days annual leave

Private health insurance

Pension scheme (ITP1)

Job summary

Qbtech is seeking a Senior Quality & Regulatory Specialist to bridge Product and Software teams with QA/RA. You will support releases, design changes, and risk assessments while ensuring quality and regulatory requirements are integrated throughout the software lifecycle.

You will manage technical documentation, Medical Device Files, regulatory submissions, and market expansion activities, with a focus on eQMS implementation and system validation.

Qualifications

• Several years of experience within Quality & Regulatory in the Medical Device industry, with clear experience in software or SaMD.
• Good knowledge of IEC 62304 and ISO 13485.
• Experience with EU MDR and/or FDA requirements.
• Good understanding of software development and technical documentation.

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.

Skills

Quality & Regulatory

Software lifecycle knowledge

Cross-functional collaboration

Regulatory submissions

Tools

eQMS

Job description

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.

• 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.

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 information

Start

As soon as possible or upon agreement.

Employment

Full-time.

Location

Remote, but be able to join the Stockholm Office 1-2 times a month.