Senior Recall Coordinator

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 Coordinator 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 inquality assurance regulatory affairs or supply chain management particularly with FDA regulations or similarheavily regulated industry
  • Experience with FDAs 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 $85200 - 133300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience skillset knowledge education business needs and market demand.
    
    Agency and Third-Party Recruiter Notice
    
    Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
    
    Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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