Senior Recall Specialist

We are seeking an experienced Senior Recall Specialist to join a growing Quality & Regulatory team supporting medical device products. This is an exciting opportunity to play a critical role in managing product field actions and recalls while helping improve processes during a period of significant regulatory activity. The ideal candidate has hands-on experience executing FDA-regulated medical device recalls and field actions and enjoys working in a collaborative, fast-paced environment where process improvement and problem-solving are highly valued.

Responsibilities

• Lead the planning, coordination, and execution of medical device field actions and recalls.
• Ensure compliance with FDA and international regulatory requirements.
• Partner with Quality, Regulatory Affairs, Operations, R&D, Legal, Marketing, and Supply Chain to develop and execute recall strategies.
• Prepare regulatory submissions and customer communications related to field actions.
• Support Health Hazard Evaluations (HHE), Health Risk Assessments, and remediation activities.
• Monitor field action effectiveness, product reconciliation, returns, quarantine, and documentation.
• Maintain accurate records and ensure regulatory compliance throughout the recall process.
• Identify opportunities to improve field action processes, documentation, and workflows.
• Participate in cross-functional teams to resolve quality and compliance issues.

Requirements

• Bachelor's degree in a scientific, engineering, or related discipline preferred.
• 5+ years of experience in Quality Assurance, Regulatory Affairs, Supply Chain, or another regulated environment.
• Direct experience managing FDA medical device recalls and field actions is strongly preferred.
• Experience working within FDA-regulated industries such as Medical Devices, Pharmaceuticals, Biotechnology, Diagnostics, or Aerospace.

Skills

• Strong understanding of:
  • FDA recall regulations
  • FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR)
  • ISO 13485
  • CAPA
  • Medical Device Reporting (MDR)
  • Complaint investigations
  • Quality Management Systems (QMS)
  • Health Hazard Evaluations (HHE)
• Hands-on recall and field action execution experience
• Strong regulatory and compliance knowledge
• Excellent organizational and project management skills
• Confidence working cross-functionally with multiple stakeholders
• Ability to prioritize competing initiatives in a fast-paced environment
• A continuous improvement mindset with strong attention to detail

What We're Looking For

We're looking for someone who has successfully executed recalls and field actions—not just supported general quality or regulatory activities. The ideal candidate is a proactive problem solver who can navigate ambiguity, improve processes, and help build structure within an evolving organization.

Benefits

• High-impact role supporting product safety and regulatory compliance
• Opportunity to improve and shape critical business processes
• Collaborative cross-functional environment
• Competitive compensation and annual bonus
• Strong opportunities for professional growth and career development

Pay

~$110,000 base + 7.5% annual bonus (flexibility for highly qualified candidates)

Schedule

• Direct hire, full-time
• Hybrid (flexible) work model
• Monday – Friday

Location: Kirkwood, DE