VP, Regulatory Affairs & Quality Assurance

Location: Copenhagen

Reports to: COO/CTO

The Opportunity

At Dawn Health, we are driven by a simple but powerful purpose: to improve the lives of patients through digital innovation.

We’re now looking for a passionate VP, Regulatory Affairs & Quality Assurance to play a key role in ensuring that our digital health products reach patients safely, efficiently, and in compliance with the highest standards. In this role, you will collaborate closely with talented colleagues across disciplines — from engineering and design to clinical and client-facing teams — and work side by side with some of the world’s leading pharma and technology partners.

This is a rare opportunity to shape how regulatory and quality excellence can empower innovation rather than slow it down.

Role Overview

As the VP, Regulatory Affairs & Quality Assurance, you will:

• Define and drive regulatory and quality strategy, roadmap, and goals-anchored in measurable outcomes for patients, users, and the business.
• Lead cross-functional teams to ensure best-in-class compliance processes while enabling agile, scalable software product development.
• Manage and develop a team of highly skilled RA/QA specialists and leaders.
• Prepare and represent the company in audits throughout the year.

What You’ll Do

Regulatory Compliance and Audit Leadership

• Lead audit preparations and represent the company with regulatory authorities, clients, and partners.
• Ensure global compliance with Dawn Health’s suite of certifications and standards.
• Continuously assess and tune the quality management system (QMS) for both documentation and technical robustness.

Bridge Regulatory, QA and Product/Engineering

• Engage in assessing regulatory and quality requirements for potential new products and business initiatives.
• Translate regulatory and quality requirements into practical, streamlined processes for software development teams.
• Drive alignment on compliance priorities with the right level of rigor - firm where necessary, adaptable where possible.

Team and Cross-Functional Leadership

• Guide, support and develop the RA/QA leaders and specialists on the team.
• Build trust-based relationships with other functional leaders and teams, finding creative, scalable solutions to regulatory and product challenges.
• Champion the adoption of pragmatic, tech-enabled compliance tools and methods.

What Success Looks Like (6–12 Months)

• Audit readiness and outcomes remain strong, with both clients and regulatory partners viewing Dawn Health as a trusted compliance leader.
• The RA/QA function is seen as a strategic partner to Product and Engineering — maintaining high standards while enabling innovation.
• Cross-functional collaboration has improved, and the team operates with greater clarity and alignment across departments.
• The RA/QA team feels empowered and supported, with clear goals, stronger ownership, and consistent development.
• Compliance requirements are integrated earlier and more efficiently in the development process, especially for non-SaMD products.
• New digital health products are launched with right-sized regulatory and quality frameworks that ensure both speed and compliance.

About You

• Experience: 10+ years of experience in regulatory affairs and/or quality assurance, with significant time spent in digital health, medtech, or software-driven environments.
• Regulatory Rigor: Proven success preparing for and navigating global audits; expert in health software regulations, including ISO 13485, ISO 27001, EU MDR, CE marking, GDPR, HIPAA, and similar frameworks.
• Technical Acumen: Demonstrated ability to communicate and collaborate with software/product teams. Bias towards creating lean, automated and scalable compliance solutions.
• Collaboration: Strong communicator and relationship builder; able to assert authority when needed and engage in collaboration on practical solutions.
• Education: Bachelor’s or Master’s degree in a relevant field (e.g., engineering, science, or health-related discipline).

Nice-to-haves / Bonus points

• Experience with the Greenlight Guru QMS.
• Experience working within or with global pharma companies.

What We Offer

• A portfolio of meaningful products that impact patient lives at scale.
• Autonomy, trust, and support to do the best work of your career.
• An open, collaborative environment with talented peers across engineering, design, clinical, and regulatory.
• Career growth in one of the leading digital health scale-ups, alongside world-class pharma partners.
• The opportunity to leave your mark on the future of digital health.
• Copenhagen’s best view and best office espresso machine ☕️

About Dawn Health

Dawn Health is a digital health company specializing in developing Software as Medical Device (SaMD) and other regulated healthcare solutions. We deliver both strategic consulting and development of innovative digital therapies targeting patients on a global scale.

Working at Dawn Health is more than just a job. We are not just looking for new employees. We are looking for deeply passionate souls, gifted minds, innovators, team players, entrepreneurs and people who believe they can change the world.

We love to build things, change the status quo, and drive a new digital health agenda that will impact 1 million patients by 2030. Our passion not only includes the urge to make a difference and Code to Save Lives — we're also very focused on our people. You’ll find warm, helpful, and friendly colleagues who care about each other and the mission we’re on.