The opportunity:
In this role, you'll dive into a dynamic industry that actively collaborates across the Pharmaceutical 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.
What you’ll do:
- Drive the regulatory strategy for digital health projects to enable global market launch.
- Support the development team in quality deliverables and activities according to our internal procedures based on IEC 62304 and ISO 27001.
- Ensure the quality of health software by adherence to the quality management system
- Support and review safety risk management & cybersecurity deliverables.
- Provide regulatory and quality consultancy within development projects.
- Communicate with pharma-clients to align on issue resolution and deliverables.
- Participate in client audits.
- Using and shaping how to use AI tools in daily work.
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 quality assurance in the life science industry. And you are interested in learning and have some knowledge within regulatory affairs.
- 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 or working experience with standards and regulations such as ISO 13485, ISO 9001, IEC 62304, GxP and/or CSV.
- Strong knowledge or working experience with quality principles such as testing, bug management, and risk-based approach in quality.
- 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 digital health products.
- Experience with standards like: ISO 14971, IEC 82304, CSV and GxP.
- Experience with regulations in the health software area beyond the EU.
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 ☕️
