Location: South Portland, ME Job Description: Support regulatory submissions, registrations, amendments, supplements, and reports for medical devices. Maintain product listings, facility registrations, licenses, approvals, and annual registrations.
Numbers & Facts
Location
South Portland, ME
Description
Hello This is Niteesh from Intellectt. I tried reaching out regarding a job opportunity that may be of interest to you. If you're currently looking for a new role or considering a change from your current position. Kindly share your updated resume at niteesh@intellectt.com
Job Title: Regulatory Affairs Specialist Location: South Portland, ME
Job Description:
Support regulatory submissions, registrations, amendments, supplements, and reports for medical devices.
Assist with SOPs, regulatory research, submission requirements, and project timelines.
Prepare and organize premarket submission and registration documents.
Maintain product listings, facility registrations, licenses, approvals, and annual registrations.
Prepare postmarket reports, regulatory communications, and other required documents.
Maintain electronic and paper regulatory records and tracking systems.
Work with regulatory agencies and serve as a liaison throughout the product lifecycle.
Support regulatory strategy, risk management, CMC activities, labeling, and manufacturing changes.
Advise marketing and development teams on regulatory requirements and interpretations.
Help ensure timely approval of new medical devices and continued approval of existing products.
Minimum Qualification: High school diploma/equivalent and 1+ year of experience.