Regulatory Affairs Specialist
Intellectt INC
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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.
Vacancy posted 2 days ago
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