Compliance Specialist 3

• Responsible for supporting regulatory compliance and quality management activities, including product recall processes, audit readiness, and regulatory reporting.
• Works closely with cross-functional teams to ensure adherence to industry standards and regulatory requirements.

Requirement/Must Have:

• Bachelor s degree in Engineering, Physical or Biological Sciences, or a related technical field.
• Minimum of 4+ years of experience in product quality or regulatory compliance in a regulated industry.
• Strong understanding of regulatory standards and quality systems.
• Excellent organizational, analytical, and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong collaboration and stakeholder management skills.

Experience:

• Experience in regulatory compliance and quality management systems.
• Experience supporting audits and maintaining audit readiness.
• Experience handling product recall or field action processes.

Responsibilities:

• Process and reconcile customer acknowledgment forms related to product recalls.
• Provide guidance to customers regarding product recall inquiries.
• Track and report effectiveness levels for field actions.
• Prepare monthly regulatory reports on field action status.
• Provide updates to cross-functional teams as required.
• Support audit readiness activities and provide information for internal and external audits.
• Assess processes and develop action plans to manage recall communications effectively.
• Maintain and improve processes within the quality management system.
• Manage recall-related communications and ensure timely resolution of issues.

Should Have:

• Knowledge of medical device regulations and international quality standards.
• Experience working with regulatory agencies.
• Familiarity with regulatory compliance tools and methodologies.

Skills:

• Regulatory compliance and quality assurance.
• Audit support and reporting.
• Process improvement and documentation.
• Communication and collaboration.

Qualification And Education:

• Bachelor s degree in Engineering, Physical or Biological Sciences, or a related field.