Quality Assurance and Regulatory Affairs Specialist

About the job

Quality Assurance and Regulatory affairs specialist to prepare and maintain comprehensive technical files, technical documentation and compliance.

Key Responsibilities:

Technical Documentation:

• Ensure all documentation is clear, accurate, and aligned with company, regulatory and quality standards.

Regulatory Compliance:

• Research and interpret regulatory requirements from relevant bodies (e.g. EDA, ISO, CE).
• Prepare and submit documentation required for regulatory approvals, certifications, and audits.
• Act as the point of contact for regulatory bodies and external auditors during inspections.

Quality Management System (QMS):

• Develop, implement, and maintain policies, procedures, and workflows to support the organization’s QMS.
• Continuously improve the QMS to ensure compliance with industry standards and best practices.

Cross-Functional Collaboration:

• Work closely with engineering, production, quality control, and other teams to gather technical information and ensure alignment with regulatory and quality standards.
• Provide training and guidance to staff on QMS processes, regulatory requirements, and documentation best practices.

Continuous Improvement:

• Proactively identify opportunities to improve documentation processes, QMS, and compliance practices.
• Monitor and report on QMS performance metrics to drive operational excellence.

Internal Audits and Compliance:

• Conduct regular internal audits to assess compliance with regulatory standards and internal policies.
• Identify gaps or non-conformities and recommend corrective actions.
• Follow up on audit findings to ensure timely resolution and continuous improvement.