Regulatory affairs manager: A unique opportunity supported by the Novo Nordisk Foundation!

The opportunity:

Many health tech startups lack the resources or expertise to effectively address regulatory issues during product development. This often leads to prolonged time-to-market and increased costs, hindering the success of innovative health technologies. We aim to change this by developing an AI-powered digital platform and an ecosystem to support regulatory processes and pathways.

Health Tech Hub Copenhagen will develop this new platform, Health Tech Pathways, backed by a substantial DKK 32 million grant from the Novo Nordisk Foundation for the next 5 years. This AI-driven platform will guide startups through the complexities of certification in both the EU and the U.S., accelerating time-to-market and increasing access to life-changing health technologies.

Our vision extends beyond regulatory aspects to include pathways for reimbursement, clinical trials, interoperability, and other challenges health tech startups face.

Join us in a startup environment with a bold, impact-driven vision and strong backing from Denmark’s largest foundation. You’ll have the opportunity to grow personally, work with a high-performing team, and significantly contribute to the future success of health tech.

Role overview:

We are seeking a skilled Regulatory Affairs Manager to join our team in developing Health Tech Pathways. The role requires a blend of strategic thinking and practical experience with regulatory pathways and challenges, particularly in relation to working with QMS, ISO-standards, MDR and FDA certifications, AI legislation and similar.

Key Responsibilities:

While one person cannot master all aspects of regulatory affairs, you will take responsibility for most of the following in close collaboration with our team, external partners, and consultants:

Content strategy and development

•  Create and implement a comprehensive content strategy for the platform.

• Decide on buy/build/partner strategies for content.

• Identify and collaborate with external content providers, starting with established Danish entities and expanding to Nordic and international markets.

• Content maintenance and quality assurance

• Establish a quality assurance process to review and validate all content before publication.

• Implement processes for continuous content updates to ensure relevance and accessibility.

• Collaboration with advisors and regulatory stakeholders

• Help establish and utilize an advisory board of relevant skills for guidance and inspiration and engage with content experts to ensure comprehensive coverage of the domain.

• Build and maintain strategic relationships with regulatory stakeholders in the Nordics, EU, and the US.

AI Tool Development

• Assist in developing and testing AI-based tools for regulatory support. Initially a chatbot for “regulatory Q&A” and later our vision includes advanced AI consulting for document creation and validation.

• Help validate potential development partners and tools.

Ecosystem development

• Curate a directory of relevant regulatory consultants, advisors, and companies for the platform, assisting in setting up partner agreements.

• Engage relevant stakeholders with relevant debates, Q&As and contribute to the formation of a knowledge exchanging community.

• Support for reimbursement and market access (longer term)

Assist in providing guidance, education, and insights related to reimbursement and market access challenges. Include content on DiGA, PECAN and NICE.

Qualifications and Skills:

• Academic background in healthcare, life sciences, technology, engineering or related fields.

• Strong understanding of quality processes in regulated industries.

• Experience bringing medtech or health tech products to market, ideally with experience in establishing and managing infrastructure for SaMD development.

• Knowledge of relevant industry standards and regulations, including MDR, ISO standards, and FDA certifications.

About You:

You are a team player, and your success depends on the team's success.

You have expertise in your field, capable of discussing and presenting regulatory issues at an advanced level.

You understand the dynamics of working in an entrepreneurial setup, adapting based on market and stakeholder feedback.

Experience within the innovation scene or with startup communities is a plus. You are enthusiastic about health and technology and ready to join our mission to make health tech accessible to everyone.

About Us:

Health Tech Hub Copenhagen (HTHC) is a non-profit, purpose-driven innovation hub, based in Copenhagen. We improve healthcare for patients and healthcare professionals through health tech. We work internationally with startups, healthcare providers, businesses, and governments to enable the development and adoption of health tech at scale.

We are a passionate team of 14 tech entrepreneurs from 7 different nationalities, valuing diverse mindsets and backgrounds in an informal and positive environment.

We have our office in cozy Copenhagen, with team activities and fun surprises. You will join a collaborative culture, working with a tight-knit, diverse team where you can learn from experienced professionals.

We believe every person should have access to good health, and to build an accessible and inclusive healthcare future, we need help from people with diverse backgrounds. Our culture emphasizes trust, openness, self-reflection, and support for individual growth. 

How to Apply:

Upload your CV and include brief motivational writeup. We are looking to fill this position as soon as possible. Applications will be evaluated, and interviews will be conducted on an ongoing basis.