Quality Systems & Regulatory Staff Lead

The Quality Systems and Regulatory Staff Lead ensures robust governance and execution of post-market quality processes, including CAPA management, issue impact determinations, field action decisions and follow-ups. This role evaluates quality signals to determine escalation, aligns investigations and corrective actions with regulatory requirements, and partners cross-functionally to scope field actions, collaborates and provides feedback on the Post Market Risk Assessment and Health Hazard Evaluation (HHE) process and facilitates its completion, and delivers data-driven insights for decision-making.

Requirements

• Support the development, execution, and governance of remediation and prevention strategies as well as post market issue impact/risk assessments.
• Evaluate potential issues before formal CAPA initiation.
• Conduct structured evaluations of quality signals, complaints, audit findings, and other inputs to determine whether formal CAPA is warranted.
• Confirm that CAPA investigations are directly tied to the reason for the recall.
• Support comprehensive issue impact and risk evaluations (SAs).
• Ensure HRA or HHE alignment by collaborating with cross-functional teams to determine the scope of field actions.
• Draft and coordinate responses to FDA warning letters, field action inquiries, and other regulatory correspondence.
• Drive End-to-End Process Improvements Throughout the Quality System.
• Leverage data analytics to uncover opportunities for benchmark and KDG refinements by analyzing quality trends (15% of the time).

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Health, Dental, and Vision Insurance
• Life Insurance
• Short-Term Disability Insurance
• Long-Term Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Savings Account
• Paid Holidays
• Vacation Time
• Sick Leave