Global Recall & Regulatory Compliance Lead

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

Job summary

Hologic, Inc. in Newark, DE is seeking a Sr. Recall Specialist to lead the preparation and execution of Field Actions for the Breast and Skeletal Health divisions.

This onsite role demands strong quality focus and the ability to coordinate with global teams to support regulatory communications. You will develop health risk assessments, support recall strategies, manage field action records, and partner with Marketing, Legal, R&D, Quality, and Regulatory teams to ensure compliant, timely

Qualifications

• BA/BS degree required.
• 5+ years in quality assurance, regulatory affairs, or supply chain in a highly regulated industry.
• Familiarity with MEDDEV 2.12/1 Guidance on Market Surveillance.

Responsibilities

• Field Action management and coordination globally.
• Develop global recall strategies and regulatory communications.
• Produce Health Risk Assessments and Health Hazard Evaluations.
• Coordinate with regulatory bodies and Notified Bodies regarding field actions.
• Track effectiveness and document Field Actions, including reconciliation of communications and removals.
• Contribute to field action process development and training.

Skills

Independent decision-making

Communication skills

Leadership

Education

BA/BS Degree

Job description

Hologic, Inc. in Newark, DE is seeking a Sr. Recall Specialist to lead the preparation and execution of Field Actions for the Breast and Skeletal Health divisions.

This onsite role demands strong quality focus and the ability to coordinate with global teams to support regulatory communications. You will develop health risk assessments, support recall strategies, manage field action records, and partner with Marketing, Legal, R&D, Quality, and Regulatory teams to ensure compliant, timely