Location
Mundelein, IL (3x days onsite T-Th, hybrid)
Duration 6-month contract, possible extension or hire
Pay Rate $28-32/hr
Requirements
Bachelor's degree
in a relevant field.
1+ 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 / food and beverage 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.
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.
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Duration 6-month contract, possible extension or hire
Pay Rate $28-32/hr
Requirements
Bachelor's degree
in a relevant field.
1+ 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 / food and beverage 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.
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.
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