Regulatory Quality Engineer

Title: Regulatory Quality Engineer

Duration: 12 Months

Location: Santa Clara, CA 95054

This role will provide quality system and compliance support to the Regulatory Affairs (RA) organization by -

• Driving preparation of KPI dashboards and maintaining a pulse on formal RA management review and internal metrics.
• Managing strategic program for RA audit preparedness including anticipatory identification of risks, mitigation of risks identified during the audit process, and preventive actions for risks.
• Investigating non-conformances (e.g., CAPAs), implementing mitigations, and monitoring effectiveness of CAPAs.
• Identifying and implementing system and/or systemic processes.
• Supporting tracking and maintenance of regulatory post-approval commitments.
• Driving quality system process improvement initiatives.

Exposure to Medical Device US and CE regulations, Quality Systems, a Quality role, or a Compliance role is a must.

• Develop and implement an "auditing plan" for critical RA tasks (e.g., mock audits for Technical Files/Technical Documentations, Impact Assessments, Archival) as part of audit risk mitigation activities.
• CAPAs/Auding Finding management.
• Key Performance Indicator results / metrics management
• Change management (change orders for procedural updates)
• Post-Approval Regulatory Commitments management
• Support QMS audits from an RA perspective
• Support QMS Integration tasks

• Independent
• Troubleshooting
• Critical thinker
• Communication and Collaboration
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously with timely execution.

5 - 7 years