Global Recall & Regulatory Compliance Lead

DIRECT SALES, US; Newark (DE); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic, Inc. in Newark, DE seeks a Sr. Recall Specialist to lead field actions globally for Breast and Skeletal Health divisions. Onsite role focuses on field action management, recall strategy development, and regulatory communications to ensure compliance and product safety.

The candidate will develop risk assessments, work with QA/Regulatory, and coordinate with international teams to tailor actions and documentation. Salary ranges reflect FDA-regulated industry standards.

Qualifications

• BA/BS degree required or equivalent.
• 5+ years in QA, regulatory affairs, or supply chain in a regulated industry.
• Experience with FDA recalls guidance and regulatory communications.
• Familiarity with MEDDEV 2.12/1 Vigilance System guidelines.
• Strong ability to assess documentation and communicate findings.

Responsibilities

• Oversee the preparation and execution of field actions globally.
• Develop global recall strategies and regulatory communications.
• Create Health Risk Assessments and Health Hazard Evaluations.
• Coordinate with Marketing, Legal, R&D, Quality and Regulatory for customer communications.
• Track effectiveness of field actions and manage records.
• Maintain documentation in Field Action records.

Skills

Field Action Management

Global Recall Strategies

Health Risk Evaluations

Customer Regulatory Communications

Tracking Documentation

Process Development Training

Education

BA/BS Degree

Job description

Hologic, Inc. in Newark, DE seeks a Sr. Recall Specialist to lead field actions globally for Breast and Skeletal Health divisions. Onsite role focuses on field action management, recall strategy development, and regulatory communications to ensure compliance and product safety.

The candidate will develop risk assessments, work with QA/Regulatory, and coordinate with international teams to tailor actions and documentation. Salary ranges reflect FDA-regulated industry standards.