Senior Regulatory Affairs Engineer (Medical Devices, AI & Software)
Location: Remote across Europe (preferred locations: Stockholm, London, Berlin)
Set-up: Direct contract with client (perm opportunity)
Panda is exclusively recruiting on behalf of an innovative health technology company developing AI-powered medical devices that are transforming preventive healthcare. We're looking for a Senior Regulatory Affairs Engineer with experience in software development, AI/ML technologies, and medical device regulations to help drive regulatory strategy across the full product lifecycle.
Key Responsibilities
- Lead regulatory activities for software, AI, and machine learning-based medical devices.
- Ensure compliance with global regulations and industry standards.
- Partner with software development teams on regulatory strategy, risk management, and product development.
- Support technical documentation and regulatory submissions.
- Guide teams in implementing regulatory requirements within the Quality Management System (QMS).
- Monitor emerging regulations and provide strategic regulatory insights.
What We're Looking For
- Bachelor's or Master's degree in Engineering, Medicine, Pharmacy, Law, or a related field.
- 5+ years' experience working with software, AI, and machine learning technologies.
- Strong knowledge of:
- EU AI Act
- FDA AI/ML Guidance
- IEC 62304
- IEC 82304-1
- IEC 81001-5-1
- Experience with SaMD, EU MDR, ISO 13485, ISO 14971, or FDA regulations is highly desirable.
- Excellent communication skills and a proactive, collaborative mindset.
- Fluent English.
Why Apply?
- Fully remote role with flexibility across Europe.
- Work on cutting-edge AI-driven healthcare technology.
- Join a mission-driven team making a real impact on patient outcomes.
Interested? Apply now or connect for a confidential discussion