Regulatory Affairs Associate II (EU MDR)
Job Description
The OperAxis team is hiring a Regulatory Affairs Associate II in Skaneateles Falls, NY (hybrid) to own EU MDR compliance and lifecycle work for connected monitoring and respiratory health medical products, including their software. Schedule is Monday to Friday, 8 AM to 5 PM. What you'll do: - Represent Regulatory Affairs on assigned product core teams - Run EU MDR activities for product changes, technical documentation, submissions and lifecycle maintenance - Assess product changes for EU MDR impact and flag compliance gaps and risks - Prepare, review and maintain EU MDR technical documentation - Write clear regulatory assessments and justifications - Support responses to EU Notified Bodies and regulatory authorities - Partner with Engineering, Quality, Clinical, Medical and Marketing to build regulatory needs into deliverables Requirements: - Bachelor's degree in a scientific, engineering, regulatory or related field - 5+ years of medical device regulatory affairs experience - Strong, hands-on EU MDR expertise across the device lifecycle - Experience with EU MDR technical documentation, change assessments and Notified Body interactions - Experience with complex medical devices and device software Preferred: - Connected monitoring or respiratory health products, including software