Regulatory Compliance Specialist (Remote)

United States

Full-time

Remote

$70K/yr - $144K/yr

New Grad, Entry Level

Stryker is hiring a Regulatory Compliance Specialist for their Endoscopy division, primarily supporting the Stryker Sustainability Solutions business unit. In this role, you will assist in post-market regulatory reporting activities to ensure the safety and effectiveness of Stryker products, including evaluating customer complaints and preparing adverse event reports.

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Responsibilities

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

Qualification

Required

Bachelor's degree, preferably in science, engineering or related field of study
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook, Teams)

Preferred

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