Hologic

Senior Recall Specialist

Hologic • $85K — $133K *
Newark, DE 19702In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BA/BS Degree preferred
  • 5+ years in quality assurance, regulatory affairs, or supply chain management
  • Experience with FDA's Industry Guidance for Recalls
  • Familiarity with MEDDEV 2.12/1 Guidance
  • Strong assessment and communication skills
  • Proven decision-making abilities in high-pressure scenarios.

Responsibilities

  • Manage and coordinate preparation and execution of global field actions
  • Participate in cross-functional meetings for developing action plans
  • Collaborate with stakeholders on recall strategies and regulatory communications
  • Coordinate with international QA/RA representatives for tailored strategies
  • Develop Health Risk Assessments and Hazard Evaluations
  • Partner with teams to create customer communications and FAQs
  • Track field action effectiveness and manage documentation processes.

Benefits

  • Opportunity to influence global recall strategies
  • Onsite position in Newark, DE offering significant local impact
  • Engagement with cross-functional teams across multiple divisions
  • Involvement in both strategic planning and execution of field actions
  • Develop expertise in regulatory communications and compliance.
Full Job Description
Job Description

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.

About Hologic

Hologic, Inc. is an American medical technology company that develops and manufactures diagnostic products, medical imaging systems, and surgical products. The company's products are used in a wide range of medical applications, including breast cancer screening, cervical cancer screening, and osteoporosis diagnosis. Hologic is headquartered in Marlborough, Massachusetts, and has operations in North America, Europe, and Asia. The company was founded in 1985 and has grown to become one of the largest medical technology companies in the world.
Learn more about Hologic
Size
6,705 employees
Market Cap
$18.5 billion
Industry
Healthcare
Net Income
$1.3 billion
Founded
1985
5 Year Trend
+9.7%
Revenue
$4.5 billion
NASDAQ
HOLX
* Ladders Estimates

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