Assist in reviewing customer complaints and determining MDR/MIR reportability based on regulatory guidelines.
Help prepare and submit initial, supplemental, and final adverse event reports within required regulatory timelines.
Support team efforts to ensure all adverse event submissions meet global regulatory deadlines.
Work with regulatory representatives, customers, and field teams to gather additional information for complaint investigations and regulatory requests.
Review complaint records prior to closure to help ensure accuracy and compliance with relevant regulations and standards.
Participate in investigations of nonconformities and contribute to corrective or preventive action activities.
Provide support during internal and external audits, including organizing documentation and assisting with data preparation.
Contribute to process improvements, maintain familiarity with applicable regulations, and support training or systems use (e.g., TrackWise) as needed.

Bachelor’s degree, preferably in science, engineering or related field of study.
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook, Teams).
Experience with medical device adverse event reporting (e.g., MDR, MIR).
Experience in a regulated industry, such as medical devices or pharmaceuticals.
Applied knowledge of applicable US and international regulations and standards (e.g., 21 CFR 803, EU MDR 2017/745, ISO 13485).
Experience with Microsoft Power Automate and/or Power BI.

Regulatory Compliance Specialist

Key skills