Regulatory Affairs Data Analyst
Tasks
- Analyze regulatory data for trends and risks
- Automate regulatory analytics
- Collaborate with regulatory quality and R and D teams
- Develop regulatory dashboards
- Ensure data integrity in regulatory systems
- Generate standard and ad-hoc reports
- Identify and implement process improvements
- Maintain regulatory databases and tracking tools
- Support global regulatory submissions
- Support post market vigilance reporting
- Support product recall data activities
Perks/Benefits
- 401k match
- Dental insurance
- Employee assistance program
- Employee stock purchase plan
- Health insurance
- Health savings account
- Healthcare Flexible Spending Account
- Incentive plans
- Life insurance
- Long-term disability leave
- Paid Holidays
- Paid time off
- Short-term disability
- Simple Steps global well being program
- Tuition assistance reimbursement
- Vision insurance
Skills/Tech-stack
Data Governance | Data Integrity | Data Visualization | Data analytics | EU MDR | Excel | FDA Submissions | ISO 13485 | ISO 14971 | Information Management | License Renewal Tracking | Medical Device | Medical Device Regulatory | Medical Device Regulatory Compliance | Microsoft Office | Post market vigilance | Power BI | Product Registration Tracking | Product registration | Python | R | Regulatory Compliance | Regulatory Information Management | SQL | Tableau
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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