Senior Recall & Regulatory Action Lead

Hologic, Inc.; Newark (DE); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic, Inc. in Newark, DE is seeking a Sr. Recall Specialist focused on Field Actions across Breast and Skeletal Health divisions.

The role is onsite and involves coordinating recall activities, developing plans, and ensuring regulatory communications meet global standards. You will collaborate with QA/RA, Marketing, Legal, and Regulatory teams to prepare health risk assessments, track field action records, and support regulatory bodies worldwide.

Qualifications

• BA/BS degree preferred.
• 5+ years of experience in quality assurance, regulatory affairs, or supply chain management, with FDA regulations.
• Familiarity with MEDDEV 2.12/1 Guidance on Medical Devices Vigilance System.

Responsibilities

• Field Action Management: Support the management and coordination of field actions globally.
• Global Recall Strategies: Collaborate with divisional stakeholders to develop global recall strategies and regulatory communications.
• Health Risk and Hazard Evaluations: Develop Health Risk Assessments, Health Hazard Evaluations, and Remedial Action Assessments.
• Customer and Regulatory Communications: Partner with Marketing, Legal, R&D, Quality, and Regulatory teams for customer communications and FAQs.
• Tracking and Documentation: Track effectiveness of field actions and reconcile communications, corrections, or removals.
• Process Development and Training: Contribute to Field Action process improvements and work instructions.

Skills

Decision making

Leadership

Regulatory knowledge

Quality assurance

Education

BA/BS Degree

Job description

Hologic, Inc. in Newark, DE is seeking a Sr. Recall Specialist focused on Field Actions across Breast and Skeletal Health divisions.

The role is onsite and involves coordinating recall activities, developing plans, and ensuring regulatory communications meet global standards. You will collaborate with QA/RA, Marketing, Legal, and Regulatory teams to prepare health risk assessments, track field action records, and support regulatory bodies worldwide.