Quality & Regulatory Coordinator #1021404

We are looking for a detail-oriented Quality & Regulatory Affairs Coordinator to support and coordinate product field actions, including product recalls.

The person in this role will help manage recall activities from initiation through completion, ensuring that all required actions are tracked, documented, communicated, and completed according to established quality procedures and applicable regulatory requirements.

This role requires strong organizational skills, project coordination experience, accurate documentation, and the ability to communicate professionally with customers, internal teams, management, and regulatory agencies.

The ideal candidate is proactive, comfortable managing multiple tasks, and capable of taking ownership of assigned field actions rather than simply performing individual administrative tasks.

Key Responsibilities

• Coordinate product recall and field action activities from initiation through completion.
• Maintain accurate records, tracking logs, project documentation, and status reports.
• Monitor timelines, outstanding activities, deliverables, and completion status.
• Coordinate with internal teams, including quality, regulatory, engineering, technical teams, management, and international partners.
• Support regulatory notifications and communications in accordance with applicable requirements, particularly FDA requirements where applicable.
• Communicate professionally with customers regarding field actions, respond to questions and concerns, and help ensure timely follow-up.
• Provide regular progress updates and identify delays, risks, or potential challenges to management.
• Follow established quality-system procedures and ensure documentation is complete and audit-ready.
• Support the development and maintenance of procedures, work instructions, and training materials.
• Assist with internal and external audits related to field actions.
• Work collaboratively with cross-functional teams to ensure field actions are completed efficiently and meet customer expectations.

Required Qualifications

• High school diploma or equivalent, with at least 2 years of relevant professional experience.
• Experience coordinating regulated activities, tracking deliverables, and maintaining execution documentation.
• Experience supporting quality processes, regulatory requirements, or other controlled procedures.
• Strong project coordination skills, including managing timelines, priorities, follow-ups, and status reporting.
• Excellent written and verbal communication skills.
• Ability to coordinate with multiple stakeholders and manage customer questions or concerns professionally.
• Strong attention to detail, organization, and time management.
• Ability to work independently, take ownership of assigned activities, and drive tasks through completion.

Preferred Qualifications

• Experience in Product Field Actions (PFA), product recalls, Quality Assurance, or Regulatory Affairs.
• Experience in the medical device industry or another regulated industry.
• Previous project coordination or project management experience.
• Experience using MS Office, SharePoint, TrackWise, Visio, or similar documentation and tracking tools.
• Experience supporting audits, regulatory communications, or international teams.

Dexian stands at the forefront of Talent Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.