Regulatory Affairs Specialist

Contract assignment length (1-2 years) (some have the chance to go direct)

Hybrid work schedule (T,W,TH on-site. Mon & Fri work remote)

(Complaint Specialist) - MDR Remediation

Seeking contingent workers to support Medical Device Reporting (MDR) remediation activities, with a focus on retrospective complaint review reportability assessments under FDA requirements.

Core Experience We Are Looking For

Candidates should have hands-on experience reviewing both historical and newly received product complaints to determine MDR reportability in compliance with FDA regulations (21 CFR Part 803). This role is remediation‑driven and requires individuals who can apply current regulatory criteria and decision logic consistently across large complaint populations.

Key Responsibilities:

• Review historical complaint files as part of a remediation or retrospective review effort to verify completeness and reassess MDR reportability decisions.
• Apply current FDA MDR definitions, criteria, and decision trees to legacy complaints to determine whether an MDR should have been filed.
• Identify missing or incomplete data within complaint records and work cross‑functionally (Quality, Regulatory, Operations, etc.) to obtain necessary information for a defensible decision.
• Prepare and submit MDRs through the FDA’s electronic MDR (eMDR) system when remediation identifies reportable events.
• Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, within strict remediation timelines.

Required Background & Skill Set

• A Bachelor’s degree in a relevant field and at least 1 year of experience in complaint handling, MDR evaluation, post‑market surveillance, or similar regulated industry experience.
• Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements.
• Strong ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.
• Experience managing high‑volume documentation reviews or participating in large‑scale remediation or retrospective review projects.
• Strong analytical skills, attention to detail, and the ability to apply updated regulatory logic consistently across many records.

Preferred Experience

• 2 years of MDR reporting or complaint remediation experience in a medical device, pharmaceutical, or healthcare environment.
• Experience working in remediation environments with aggressive deadlines and throughput expectations.
• Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.

Key Traits & Behavioral Attributes for Success:

• Strong attention to detail – Able to carefully review complaint records, medical narratives, and regulatory fields to ensure accuracy and audit‑defensible MDR decisions
• Clear and professional communication skills – Comfortable documenting rationale, escalating questions, and collaborating cross‑functionally to resolve missing or unclear data
• Quick learner – Able to rapidly understand internal procedures, MDR decision logic, and remediation workflows in a fast‑paced environment
• Analytical and critical thinking skills – Capable of applying current MDR definitions and regulatory criteria consistently across large volumes of legacy complaints
• Time management and prioritization skills – Able to manage high‑volume remediation work while meeting strict regulatory and remediation timelines
• Comfort working in structured, compliance‑driven environments – Understands the importance of following procedures and producing consistent, traceable decisions