Regulatory Affairs Associate II at JPC TECHNO INC · Skaneateles, NY · Joined
JI
Regulatory Affairs Associate II
JPC TECHNO INC · Skaneateles, NY · Just now · 0 applicants
NewOn-siteFull-timeSenior
Pay
Pay not listed
Workplace
On-site
Job type
Full-time
Level
Senior
Source: jobright · Posted by joined-scrapper
About the role
JPC TECHNO INC is hiring a Senior-level Regulatory Affairs Associate II to support EU MDR compliance and lifecycle activities for Baxter Connected Monitoring and Respiratory Health medical products, including software. The role involves executing regulatory activities, maintaining technical documentation, assessing product changes, and collaborating with cross-functional teams.
What you’ll do
Execute regulatory activities for medical products
Maintain technical documentation
Assess product changes
Collaborate with cross-functional teams
What you’ll need
Bachelor's degree or equivalent in scientific, engineering, regulatory, or related discipline
Minimum 5 years of Regulatory Affairs or related medical device experience
Experience with complex medical devices and medical device software
Strong EU MDR regulatory expertise
Experience with EU MDR technical documentation, change assessments, and Notified Body interactions
Regulatory experience with Connected Monitoring and/or Respiratory Health medical products
Original job description
JPC TECHNO INC is seeking a Regulatory Affairs Associate II to support EU MDR compliance and lifecycle activities for Baxter Connected Monitoring and Respiratory Health medical products, including software. The role executes regulatory activities, maintains technical documentation, assesses product changes, and collaborates with cross-functional teams.…