Regulatory Affairs Associate

Hiring: Regulatory Affairs Associate | Entry-Level

Location: South Portland, ME 04106 (On-site role)

Duration: 12 months, with possible extension

Hours: Monday–Friday, 7:00 AM–4:30 PM

Pay: $23/hour on W-2

We are currently seeking an Entry-Level Regulatory Affairs Associate to join the IVDR Regulatory Affairs team in South Portland, Maine.

This is an excellent opportunity for someone looking to build hands-on experience in Regulatory Affairs within the medical device/IVDR environment.

🔹 Key Responsibilities

• Support the preparation and coordination of regulatory submissions, amendments, reports, and registration packages.
• Research regulatory requirements, procedures, and changes in the regulatory landscape.
• Assist with SOP development, review, and implementation.
• Track regulatory projects, timelines, submissions, and approvals.
• Coordinate and organize premarket submission materials.
• Perform quality checks of regulatory documents and submission packages.
• Maintain global product listings, facility registrations, licenses, and approvals.
• Support postmarket reports, regulatory communications, and submissions.
• Maintain electronic and paper regulatory documentation and archives.
• Prepare regulatory documentation for registrations, imports/exports, tenders, and other business needs.
• Serve as a regulatory liaison throughout the product lifecycle.
• Support regulatory strategy, product planning, risk management, and manufacturing-related activities.
• Provide regulatory support to marketing, research, development, and other cross-functional teams.

Qualifications

• Entry-level opportunity — approximately 0–1 year of relevant experience.
• Technical Diploma, High School Diploma, or equivalent.
• Interest in Regulatory Affairs, Medical Devices, IVDR, Life Sciences, or a related field.
• Strong organizational, communication, documentation, and research skills.
• Ability to work effectively with cross-functional teams.
• Ability to manage multiple priorities and meet deadlines.

Important: Although the responsibilities may reference experienced/paraprofessional-level work, this position is specifically approved as a lower-level, entry-level Regulatory Affairs role within the IVDR group.

Interested candidates are encouraged to apply or reach out for more information.

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