• Develop and maintain KPI dashboards and regulatory metrics to support RA management reviews.

• Lead audit preparedness initiatives, including risk identification, mitigation, and preventive actions.

• Support Quality Management System (QMS) integration for acquisitions and new product introductions.

• Drive quality system and process improvement initiatives, including change management activities.

• Track and maintain regulatory post-approval commitments.

• Establish and support audit readiness for integrated products, including mock audits.

• Partner with cross-functional teams and international affiliates to meet regulatory compliance requirements.

• Participate in audit backrooms and support Regulatory Affairs projects.

Core Tasks

• Manage change orders and procedural updates.

• Develop and execute audit plans for critical RA activities (e.g., Technical Files, Technical Documentation, Impact Assessments, Archival).

• Manage CAPAs and audit findings, including investigation and mitigation.

• Support QMS audits from a Regulatory Affairs perspective.

• Assist with QMS integration activities.

• Prepare and report management review metrics.

Qualifications & Skills

• Strong understanding of Quality Systems and regulatory compliance.

• Experience supporting audits, CAPAs, and change management.

• Exposure to U.S. FDA and CE medical device regulations preferred.

• Ability to work independently and manage multiple priorities.

• Strong troubleshooting, critical thinking, and problem-solving skills.

• Proven ability to drive issues through resolution and implement effective mitigations.

• The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable).