Regulatory Compliance Specialist
Stryker
full-time
Posted on:
Location Type: Remote
Location: Arizona • California • United States
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Salary
💰 $69,500 - $144,200 per year
About the role
- 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.
Requirements
- 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.
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
adverse event reportingMDRMIRregulatory compliancedata preparationprocess improvementscorrective actionpreventive actioninvestigationsdocumentation accuracy
Soft Skills
communicationteam collaborationorganizational skillsattention to detailproblem-solving