We're Hiring: Regulatory Affairs Specialist – Medical Devices
Location: Remote - United States
Experience: 5+ Years
Required Skills & Experience
- Minimum 5+ years of Regulatory Affairs or related medical device experience.
- Strong, hands-on expertise in EU Medical Device Regulation (EU MDR).
- Experience with complex medical devices and medical device software.
- Experience with EU MDR technical documentation, change assessments, and Notified Body interactions.
- Regulatory experience with Connected Monitoring and/or Respiratory Health products.
- Strong understanding of medical device product lifecycle compliance.