Recall Coordinator 1

Hologic•Newark, DE

1d•$94,000 - $146,900•Onsite

About The Position

Are you a quality-focused professional with a passion for ensuring product safety and compliance in the medical device industry? We are seeking a dynamic Recall Coordinator to oversee the preparation and execution of Field Actions for our Breast and Skeletal Health divisions. Based in Newark, DE, this pivotal role requires onsite presence and offers the opportunity to make a significant impact on global recall strategies and regulatory communications.

Requirements

2-5 years of experience with 21 CFR Part 7 Subpart C – Recalls, 21 CFR Part 806 Medical Device: Reports of Corrections and Removals, FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding field safety corrective actions.
Experience with FDA’s Industry Guidance for Recalls and guidance on distinguishing medical device recalls from enhancements.
Familiarity with MEDDEV 2.12/1 Guidance on Market Surveillance – Guidelines on Medical Devices Vigilance System.
Ability to assess written product and project documentation as the principal advocate for compliance and effectively communicate assessments.
Demonstrates independent decision-making and prioritization, including resolving conflicts and taking leadership roles on critical tasks.

Responsibilities

Support the management and coordination of the preparation and execution of field actions globally.
Participate in cross-functional meetings to develop plans and deliverables for various activities supporting Field Actions.
Collaborate with divisional stakeholders to develop comprehensive global recall strategies and regulatory communications.
Coordinate with Hologic international QA/RA representatives to tailor regional recall strategies and regulatory communications.
Develop Health Risk Assessments, Health Hazard Evaluations, and Remedial Action Assessments.
Work closely with Quality on processing Field Action records in Agile.
Partner with Marketing, Legal, R&D, Quality, and Regulatory teams to develop customer communications and Hologic field personnel FAQs.
Support communications and meetings with regulatory bodies, Notified Bodies, and competent authorities regarding field actions.
Track the effectiveness of field actions, including reconciliation of communications, corrections, and/or removals.
Reconciliation, quarantine, and destruction of returned product
Maintain and attach supporting records and documentation to Field Action records.
Feed into the Field Action process and supporting work instructions