Senior Recall & Compliance Lead – Global Field Actions

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

Job summary

Hologic, Inc. in Newark, Delaware is seeking a Sr. Recall Specialist to lead Field Actions for Breast and Skeletal Health.

This onsite role oversees preparation and execution of field actions globally and contributes to regulatory communications and recall strategies. You will collaborate with QA/RA, Marketing, Legal, and R&D to develop plans, track action effectiveness, and maintain documentation. The base salary ranges from $85,200 to $133,300 per year and is bonus-eligible; final compensation

Qualifications

• BA/BS degree in a relevant field.
• 5+ years of experience in quality assurance, regulatory affairs, or supply chain in FDA-regulated industry.
• Familiarity with FDA recalls guidance and MEDDEV 2.12/1.

Responsibilities

• Support field action preparation and execution globally.
• Develop global recall strategies and regulatory communications with stakeholders.
• Develop health risk assessments and coordinate with QA/RA teams.
• Create customer communications and regulatory meeting materials.
• Track field action effectiveness and maintain records.
• Contribute to process development and training for Field Actions.

Skills

Field Action Management

Global Recall Strategies

Health Risk Assessments

Regulatory Communications

Documentation Tracking

Process Development

Education

BA/BS Degree

Job description

Hologic, Inc. in Newark, Delaware is seeking a Sr. Recall Specialist to lead Field Actions for Breast and Skeletal Health.

This onsite role oversees preparation and execution of field actions globally and contributes to regulatory communications and recall strategies. You will collaborate with QA/RA, Marketing, Legal, and R&D to develop plans, track action effectiveness, and maintain documentation. The base salary ranges from $85,200 to $133,300 per year and is bonus-eligible; final compensation