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Product Recall Specialist- Medica Device

Product Recall Specialist- Medica Device

Artech LLCLakewood, CO
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Role : Product Recall Specialist- Medica Device

Location : LakeWood, CO

Rate : $30-40 / hr on W2.

The Sr. Global Recall Specialist plays a critical role in leading and managing all product recall, field action and market recall activities in compliance with FDA 21 CFR Part 7, 21 CFR Part 806, ISO 13485 : 2016, and other applicable international regulatory requirements. This role serves as the central liaison between the company, regulatory authorities, and global functional teams to ensure swift, compliant, and effective execution of both voluntary and mandatory product recalls.

This individual will drive end-to-end recall lifecycle management, facilitate cross-functional coordination, maintain thorough documentation, and continuously improve recall processes—all while keeping patient safety and regulatory compliance as the highest priorities.

ESSENTIAL DUTIES

Recall Initiation & Execution

  • Lead and manage the full lifecycle of global product recalls, corrections, and removals.
  • Identify affected products and lots using traceability tools and internal systems (e.g., ERP, WindChill).
  • Define and execute containment, communication, and distribution strategies based on risk assessments.
  • Draft and implement comprehensive recall strategies including scope, depth, methods of contact, and timelines.

Regulatory Liaison & Compliance

  • Serve as the primary point of contact with the FDA Recall Coordinator , global competent authorities, and regulatory agencies.
  • Ensure timely submission of recall notifications, updates, and status reports to FDA and international regulatory bodies.
  • Maintain full compliance with 21 CFR Part 7, 21 CFR Part 806 , and ISO 13485 standards related to nonconformance, corrective action, and post-market surveillance.

    • Cross-Functional Coordination

  • Collaborate with QA, RA, Legal, Supply Chain, Sales, Customer Service, and Field Service to coordinate recall activities and minimize disruption to customers and patients.
  • Lead cross-functional recall teams to ensure rapid and aligned decision-making during recall events.
  • Work with internal stakeholders to define risk classification, customer notification strategy, and escalation procedures.

    • Documentation & Recordkeeping

  • Maintain detailed and audit-ready documentation of all recall activities, including risk assessments, root cause analysis, CAPA, communications, response tracking, and effectiveness checks.
  • Ensure all records are maintained per FDA, ISO, and internal QMS requirements.

    • Training & Readiness

  • Develop, maintain, and conduct recall training programs and periodic mock recall drills to ensure global team preparedness.
  • Ensure field action SOPs and work instructions are current, effective, and aligned with evolving regulations

    • Team Leadership and Development

  • May lead and manage a recall workforce or temporary staffing, including requisitioning, work assignment, performance monitoring, and timecard approval.
  • Develops and implements recall training and mock recall exercises to ensure team preparedness and compliance.
  • Fosters a positive working environment and promotes teamwork, collaboration, accountability, and continuous improvement.
  • Provides guidance and support to junior team members or cross-functional partners involved in recall activities.

    • Metrics, Reporting & Continuous Improvement

  • Track key recall performance indicators (e.g., time to initiation, time to closure, response rate, effectiveness).
  • Analyze trends in product complaints, deviations, and quality events to identify and mitigate potential recall risks.
  • Propose and implement process improvements to enhance recall efficiency and reduce recurrence.
  • Contributes to recall-related process improvements and other Quality Management System (QMS) process improvements and execution.
  • Identifies and communicates possible improvements in work processes for customers and peers.
  • Writes trend analysis and risk assessments related to recalls and product quality.

    • MINIMUM QUALIFICATION REQUIREMENTS

    Education

  • Education : Bachelor's Degree, preferably in a science-related field, Quality Assurance, Regulatory Affairs, Engineering, or a related field.

    • Experience :

  • Five plus (5+) years of progressively responsible experience in Quality and / or Regulatory functions in the medical device or similar regulated industry.
  • Two plus (2+) years of hands-on experience managing Field Alert Reports (FARs), recalls, and related processes in the pharmaceutical or medical device industry.
  • Demonstrated leadership experience in managing teams, projects, or functional areas.

    • Preferred Qualifications :

  • Master's degree in Regulatory Affairs or a related field.
  • Certification in Quality Management (e.g., Certified Manager of Quality / Organizational Excellence) or Regulatory Affairs (e.g., RAC from the Regulatory Affairs Professionals Society).
  • Direct hands-on experience in manufacturing or development of a medical device.
  • Knowledge of international product registration support.
  • Regulatory Knowledge : Deep understanding of medical device regulations including FDA 21 CFR Part 820 (QSR), Part 7, 806, 810, and other applicable global regulations related to recall management.

    • Skills

  • Proficiency in Client applications, including Excel, Word, and PowerPoint.
  • Experience with recall management software (e.g., WindChill, SAP) is a plus.
  • Experience with data analysis for identifying trends and metric generation and reporting.
  • Excellent written and verbal communication skills with the ability to effectively communicate at multiple levels within the organization and with external stakeholders.
  • Strong organizational skills, attention to detail, and the ability to manage multiple tasks and prioritize work to meet deadlines in a fast-paced environment.
  • Strong analytical and problem-solving skills, with the ability to exercise sound judgment.
  • Ability to work independently and as part of a team, fostering a collaborative environment.
  • Strong sense of responsibility, self-motivation, and the ability to function effectively under pressure to meet regulatory reporting requirements.

    • Preferred Certifications (Not Required) :

  • RAC (Regulatory Affairs Certification)
  • ISO 13485 Lead Auditor Certification
  • ASQ Certified Quality Auditor (CQA) or similar

    • LOCATION

    Lakewood, Colorado - Onsite (hybrid)

    TRAVEL / HOURS

  • May require domestic or international travel based on business needs. Likely less than 10%.
  • Must be available to respond to critical recall events beyond regular business hours if needed.

    • PHYSICAL REQUIREMENTS

  • General Labor Environment requirements include : use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching / reaching, hand / finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
  • The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
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    Product Specialist • Lakewood, CO