Senior Recall Specialist

Hologic, Inc.; Marlborough (MA); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic, Inc. in Newark, DE is seeking a Sr. Recall Specialist to lead the preparation and execution of Field Actions for the Breast and Skeletal Health divisions.

This onsite role demands strong quality focus and the ability to coordinate with global teams to support regulatory communications. You will develop health risk assessments, support recall strategies, manage field action records, and partner with Marketing, Legal, R&D, Quality, and Regulatory teams to ensure compliant, timely

Qualifications

• BA/BS degree required.
• 5+ years in quality assurance, regulatory affairs, or supply chain in a highly regulated industry.
• Familiarity with MEDDEV 2.12/1 Guidance on Market Surveillance.

Responsibilities

• Field Action management and coordination globally.
• Develop global recall strategies and regulatory communications.
• Produce Health Risk Assessments and Health Hazard Evaluations.
• Coordinate with regulatory bodies and Notified Bodies regarding field actions.
• Track effectiveness and document Field Actions, including reconciliation of communications and removals.
• Contribute to field action process development and training.

Skills

Independent decision-making

Communication skills

Leadership

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 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.

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