Regulatory Affairs Leader for AI Medical Device Development
Vor 2 Tagen
Contextflow is an award-winning startup at the forefront of developing cutting-edge artificial intelligence-based software applications to support radiologists during their clinical routine. As a recognized leader in medical device software innovation, we are expanding our team and seeking a highly skilled Regulatory Affairs expert.
About the RoleWe are looking for a seasoned Regulatory Affairs Leader to join our interdisciplinary team and play a pivotal role in ensuring the regulatory compliance of our devices, including risk management, post-market surveillance, clinical evaluation, market clearance, product labeling, and product registration. This is a full-time position with flexible working hours and remote work options available.
This is a unique opportunity to be part of a dynamic learning environment where you can grow professionally and contribute significantly to the development of AI medical device software products. You will have the chance to work directly with our founders, influence the company's actions, and make meaningful contributions to its value proposition.
Responsibilities- Regulatory Compliance: Own and ensure regulatory compliance of our devices, including risk management, post-market surveillance, clinical evaluation, market clearance, product labeling, and product registration.
- Regulatory Strategies: Define regulatory strategies for new products to be placed in applicable markets.
- Quality Management System: Own and maintain corresponding processes within our ISO 13485-certified Quality Management System.
- Product Development Support: Support our product development team in the development of AI-based image analysis solutions.
- Sales Material Creation: Support our marketing team in creating regulatory-compliant sales materials.
We are looking for a candidate with:
- Experience with regulating/clearing Software as a Medical Device under MDR.
- Experience with corresponding applicable standards and norms (ISO 13485, ISO 14971, IEC 62304, IEC 62366, ISO 27001).
- Experience with regulating/clearing AI-based image analysis solutions within radiology.
- Experience with market clearance in the US.
- Background in IT, Medical Imaging, or any other relevant scientific discipline.
- Ability to work independently.
- Structured work style and high level of self-motivation.
- Strong belief in growing together as a team and having empathy for each other.
- Experience with leading & growing teams.
- Open to travel on a quarterly/monthly basis.
- Fluency in English.
$120,000 - $150,000 per year, depending on experience and qualifications.
Bonus Skills- Experience with ensuring regulatory compliance of agile development processes.
- Experience with MDSAP.
- German, Dutch, or any Scandinavian language a plus.
You will become part of an interdisciplinary team characterized by close collaboration and sharing of knowledge across boundaries of individual fields. We prioritize the well-being of all team members and take care of each other so that we can grow together. We place a huge emphasis on continuous learning and professional growth. Our team thrives in a young, dynamic environment where everyone has the opportunity to grow professionally.
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