Compliance Specialist III

Field Action Quality Specialist

We are seeking a Field Action Quality Specialist to support product recall and field action activities within a regulated environment. This role serves as a key liaison between customers, quality teams, regulatory functions, and cross-functional stakeholders to ensure timely processing, documentation, reporting, and communication related to field actions. The ideal candidate combines regulatory knowledge, strong organizational skills, and a customer-focused approach to support compliance and audit readiness objectives.

Responsibilities include:

• Process, reconcile, and maintain customer acknowledgment forms in accordance with regulatory requirements and internal procedures.
• Serve as a point of contact for customer inquiries related to product recalls and field actions.
• Monitor and report field action effectiveness metrics and support ongoing effectiveness assessments.
• Assist in preparing monthly regulatory reports and status updates related to field action activities.
• Communicate field action progress, risks, and key updates to cross-functional teams and stakeholders.
• Support audit readiness efforts by maintaining accurate documentation and providing information required for internal and external audits.
• Manage and prioritize field action and recall-related communications, ensuring urgent matters are addressed appropriately.
• Perform assessments, develop action plans, and support execution of activities to improve field action processes and effectiveness.
• Collaborate with quality, regulatory, and business partners to maintain and enhance quality system procedures and processes.
• Support document retention and records management activities in accordance with company policies and regulatory requirements.
• Assist with escalation management and resolution of customer concerns related to field actions and product recalls.

Requirements include:

• Bachelor's degree in Engineering, Physical Sciences, Biological Sciences, or another technical discipline.
• Minimum of 4 years of experience in product quality, regulatory compliance, or a combination of related experience within a regulated industry.
• Experience supporting product recalls, field actions, quality systems, or regulatory compliance activities.
• Working knowledge of U.S. medical device regulations, including 21 CFR Part 820 and 21 CFR Part 11.
• Familiarity with international quality and regulatory standards, including ISO 13485 and ISO 14971.
• Strong organizational, written, and verbal communication skills.
• Strong analytical, critical thinking, and problem-solving abilities.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Experience collaborating across cross-functional teams and managing stakeholder relationships.
• Proficiency with standard business software and electronic documentation systems.

Preferred Qualifications include:

• Experience within the medical device industry.
• Familiarity with international regulatory requirements, including Canada, European Union, and Brazil regulations.
• Experience with computer system regulations, validation standards, or related methodologies.
• Experience interacting directly with regulatory agencies, including the FDA, Notified Bodies, or other governmental authorities.
• Experience supporting internal and external audits.
• Knowledge of quality management systems and continuous improvement methodologies.
• Experience managing customer communications related to quality, compliance, or field action activities.