Senior Recall Specialist

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

Job summary

Hologic, Inc. in Newark, DE is seeking a Sr. Recall Specialist to oversee the preparation and execution of Field Actions for our Breast and Skeletal Health divisions, with onsite requirements and global recall responsibilities.

You will lead cross-functional plans, develop recall strategies, health risk evaluations, and regulatory communications, while coordinating with QA/RA and regional teams. The role emphasizes tracking, documentation, training, and interaction with regulators, Notified

Qualifications

• BA/BS degree minimum preferred.
• 5+ years in quality assurance, regulatory affairs, or supply chain within a heavily regulated industry (FDA/medical devices).
• Familiarity with FDA recalls guidance and MEDDEV 2.12/1 guidance.

Responsibilities

• Oversee global field action preparation and execution.
• Develop global recall strategies and regulatory communications.
• Create health risk assessments and remedial action plans.
• Coordinate with Marketing, Legal, R&D, Quality and Regulatory for communications.
• Track field action effectiveness and maintain records/documentation.
• Contribute to Field Action processes and training materials.

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 inquality assurance, regulatory affairs, or supply chain management, particularly with FDA regulations or similarheavily 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.
  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 Department. In 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.

• #LI-AV1