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Senior Recall Specialist
Posted: 07/22/2026
Industry: Scientific and Life Sciences
Job Number: 19363
Security Clearance: NA / not required
Work Model: Hybrid
Job Description
Title: Senior Field Action & Recall Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
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
Qualifications
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.
Successful candidates will demonstrate:
Why Apply?
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, we'd 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. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
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
- 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.
- 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 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.
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, we'd 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. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Meet Your Recruiter
Emily Donahue
Regional Recruiting Manager
- Directs the recruitment efforts for both the Quincy, MA and Providence, RI branches.
- Manages a distributed team of recruiting leads, individual contributor recruiters and account managers.
- Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region.
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Are you ready to take your career to new heights in Kirkwood, Delaware? Discover exciting job opportunities in this vibrant area that boasts a rich history and promising future. With its close proximity to major cities like Wilmington and Philadelphia, Kirkwood offers a unique blend of small-town charm and big-city amenities. Explore career possibilities while enjoying the scenic beauty of White Clay Creek State Park or catching a show at the historic Grand Opera House. Indulge in local delicacies like crab cakes and fresh seafood, immerse yourself in the arts at the Delaware Art Museum, or cheer on the Wilmington Blue Rocks baseball team at Frawley Stadium. Join us in Kirkwood and unlock a world of career growth and cultural experiences!