Hologic

Senior Recall Specialist

Hologic • $85K — $133K *
Marlborough, MA 01752In-Person
Healthcare
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Preferably a BA/BS degree in a related field.
  • Over 5 years of experience in quality assurance, regulatory affairs, or supply chain management in a regulated industry.
  • Strong knowledge of FDA regulations regarding recalls and distinguishing device recalls from enhancements.
  • Familiarity with MEDDEV 2.12/1 guidelines on medical device vigilance.
  • Proven ability to communicate compliance assessments effectively.
  • Demonstrated independent decision-making and conflict resolution skills.

Responsibilities

  • Manage and coordinate global field actions preparation and execution.
  • Participate in cross-functional planning meetings for field action deliverables.
  • Collaborate with stakeholders to develop global recall strategies.
  • Tailor regional recall strategies with international QA/RA representatives.
  • Develop health risk and hazard assessments for field actions.
  • Partner with multiple teams to create customer communications and FAQs.
  • Track the effectiveness of field actions and maintain documentation.

Benefits

  • Dynamic work environment focused on impact.
  • Opportunity to work on global strategies for regulatory communications.
  • Collaborative culture involving cross-functional teamwork.
  • Hands-on involvement in health risk evaluations.
  • Onsite presence in Newark, DE for direct engagement.
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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