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 regulatory/quality/clinical team in Copenhagen.

The opportunity:

If you are ready to dive into the dynamic world of regulatory, quality, and clinical, you should join us at Dawn Health, where we are on the lookout for someone for our RA/QA/Clinical team. As part of our team, you will collaborate closely with a diverse range of experts, from Project Managers to Software Engineers, develop cutting-edge digital health products and bring them to the global marketplace. If you're passionate about making a real difference in patients' lives and eager to explore every aspect of the processes, we've got the training and the team for you.

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 +2 years of experience working with RA/QA and/or Clinical tasks.
• Experience with one or more of standards/regulations like: ISO 13485, FDA 21CFR820, ISO 14971, ISO 14155, and MDR.
• You strive to handle a wide range of tasks in a dynamic environment.
• You have a relevant educational background in biotech, pharmaceutical sciences, biomedical engineering, biochemistry, or similar.
• You have professional proficiency in English.

It is a bonus if you have:

Experience working with Software as a Medical Device (SaMD) documentation, like:

• PostMarket Clinical Follow-up
• Clinical evaluation
• Clinical trial protocol and reporting
• Regulatory strategies
• Usability engineering
• Risk management

Your responsibilities:

• Provide regulatory, quality, and clinical consultancy within new product development projects.
• Support with clinical evaluation reporting.
• Ad-hoc clinical trial support together with our pharma clients.
• Drive and review documentation deliverables in close collaboration with project managers.
• Development and maintenance of regulatory and clinical strategies.
• Support and review patient safety and cyber security risk management deliverables.

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.