Title:

Senior Field Action & Recall Specialist Hiring Organization:

Connexion Systems & Engineering Compensation, Benefits, and Employment Type Duration:

direct hire, full-time Pay rate: ~$110,000 base + 7.5% annual bonus (flexibility for highly qualified candidates)

Job Location:

Kirkwood, DE Work Model:

Hybrid (flexible)

Schedule:

Monday - Friday Job#: bh19363

Description:

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. Key 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. Qualifications Bachelors 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.

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) What Were Looking For Were 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.

Successful candidates will demonstrate:

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 Why Apply? 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 If you have experience leading medical device recalls or field actions and are looking for an opportunity to make a meaningful impact within a highly regulated industry, wed love to hear from you. Please use the apply button to submit your resume for consideration. You will receive a brief survey via email to complete your application. Applicants who complete the survey will receive priority consideration. You can review our other job postings at https://jobs.csetalent.com/. If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job! Connexion's mission is to provide \"best in class\" services to job seekers. 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