Regulatory Specialist

Position: Adverse Event Specialist

Shift: 1st (7a-3:30pm, flex)

Location: Mundelein, IL (3x days onsite T-Th, hybrid)

Duration: 6-month contract to hire

Pay Rate: $30-35/hr

Start Date: ASAP

Requirements:

• Bachelor's degree in a relevant field.
• 2+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.
• Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.
• Experience in a regulated industry (pharmaceutical / medical device industry).
• Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.
• Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.

Preferred:

• Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).
• Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.
• Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.

Insight Global is seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.

Responsibilities:

• Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.
• Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision.
• Work cross functionally with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information required for accurate reportability assessments.
• Prepare and submit MDRs through the FDA’s electronic submission portal (eMDR) for newly identified reportable events.
• Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.