Regulatory Affairs Consultant II #2642 at ECI · United States · Joined
E
Regulatory Affairs Consultant II #2642
ECI · United States · Just now · 0 applicants
NewRemoteContractSenior
Pay
Pay not listed
Workplace
Remote
Job type
Contract
Level
Senior
Team: Regulatory Affairs · Source: jobright · Posted by joined-scrapper
About the role
ECI is seeking a Senior-level Regulatory Affairs Consultant to support medical device product changes and regulatory submissions, including 510(k) approvals and post-market activities. The role requires strong Class II regulatory experience, software/firmware knowledge, and the ability to work remotely while supporting West Coast hours.
What you’ll do
Support medical device product changes and regulatory approvals or clearances
Prepare and manage change assessments and 510(k) submissions
Support product maintenance and post-market activities
Represent Regulatory Affairs to other departments
Participate in and facilitate cross-functional teams
Provide regulatory planning and strategy for submissions
What you’ll need
Minimum 5 years of directly related Regulatory Affairs experience in the medical device industry
Hands-on FDA 510(k) submission and lifecycle support experience
Strong Class II regulatory experience; Class III knowledge a plus
Software and/or firmware experience with complex medical device systems
Ability to manage multiple projects and facilitate teams in a fast-paced environment
Proficiency in regulatory planning and strategy for 510(k)/IDE/PMA submissions
Original job description
ECI provides professional consulting services to the life sciences industry. The Regulatory Affairs Consultant II supports medical device product changes and regulatory approvals or clearances, including change assessments, 510(k) submissions, product maintenance, and post-market activities.Strong software and/or firmware experienceExperience with…