Dawn Health is a leading Digital Health product company that empowers Life Science companies to create elegantly designed digital solutions quickly and in compliance with the highest quality and reliability standards. We are looking for someone to join our Project RA/QA team in Copenhagen.

The opportunity:

In this role, you'll dive into a dynamic industry that actively collaborates across the Pharmaceutical, Medical Device, and Technology sectors and you will collaborate closely with experts across the entire organization. We are seeking a dedicated, skilled, and independent Senior Regulatory Affairs and Quality Assurance Professional to join our team. The successful candidate will play a critical role in ensuring that development projects have a strong regulatory strategy and are adhering to internal and external quality standards. You'll enjoy a high degree of freedom to influence your daily work and contribute to the overall development of the company.

About you:

• You are driven by the same purpose as us and want to contribute to improving the lives of patients around the world.
• You have a positive and curious mindset.
• You understand how to balance quality and pragmatism to ensure the best possible outcome for a given project.
• You are looking for a fun, friendly, and tolerant working environment in a purpose-driven company where your opinion matters.
• You have +5 years of experience working with regulatory affairs and/or quality assurance in the life science industry. And you are interested in learning and working within both areas.
• You pose a strong understanding and experience with design control, qualification and classification of medical devices, technical documentation and supporting project members in the principles of quality assurance.
• Strong knowledge of working experience with standards and regulations such as ISO 13485, IEC 62304 and the Medical Device Regulation (MDR).
• You have a relevant educational background, e.g. biomedical engineering, software engineering or other relevant areas of science or engineering.
• You strive with being part of several projects and can readily adapt to changes.
• You have professional proficiency in English.

It is a bonus if you have:

• Experience working with Software as a Medical Device (SaMD) or digital health products.
• Experience with standards like: ISO 14971, IEC 82304, and IEC 62366.
• Experience with regulations beyond the EU.

Your responsibilities:

• Drive the regulatory strategy for digital health projects to enable global market launch.
• Support software engineers in software deliverables in accordance with IEC 62304 and our internal procedures.
• Support and review safety risk management & cybersecurity deliverables.
• Support and review SaMD technical documentation and drive submission processes for e.g. EU notified body.
• Provide regulatory and quality consultancy within development projects.
• Ensuring that projects adhere to the quality management system.

What we offer:

• A chance to work alongside innovative colleagues who are great at what they do and are happy to share their knowledge.
• An open, informal, and friendly atmosphere, that we are proud of and nourish.
• A broad range of meaningful projects and products.
• Autonomy, self-leadership, and confidence in you and your abilities.
• Celebration of our wins and social events on a regular basis to meet and get to know all the Dawn employees.
• Approved training budget

About us:

Dawn Health is a digital health company specializing in developing Software as Medical Device (SaMD) and other regulated digital 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 more than 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. There is a great social culture at Dawn Health, and throughout the company you will find warm, helpful, and friendly colleagues. When we hire, we do not just look for professional skills and talent, we look for people who will thrive in our environment and who will make a good addition to the team and contribute to the culture.

Our DNA:

We hire people with a broad set of technical skills who are ready to take on some of technology's greatest challenges and make an impact on millions of patients. At Dawn Health, engineers not only revolutionize the healthcare industry, but they also routinely work on innovation projects with the potential to become large-scale applications and entirely new digital health platforms.