Senior Recall Specialist

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

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 Sr. Recall Specialist 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.

• Field Action Management:
  • 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.
• Global Recall Strategies:
  • 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.
• Health Risk and Hazard Evaluations:
  • Develop Health Risk Assessments, Health Hazard Evaluations, and Remedial Action Assessments.
  • Work closely with Quality on processing Field Action records in Agile.
• Customer and Regulatory Communications:
  • 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.
• Tracking and Documentation:
  • 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.
• Process Development and Training:
  • Feed into the Field Action process and supporting work instructions

Qualifications:

Education:

• Preferred Minimum Technical Degree: BA/BS Degree

Experience:

• 5 Plus years of experience in quality assurance, regulatory affairs, or supply chain management, particularly with FDA regulations or similar heavily regulated industry
• 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.

Skills:

• 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.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $85,200 - 133,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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