Senior Regulatory Compliance Specialist

About the role

The Senior Regulatory Compliance Specialist will lead both planned and unplanned audits to verify that our operations meet government regulations, Quality System Regulations (QSR), Good Manufacturing Practices (GMP), ISO standards and internal policies. The role provides guidance on compliance matters and supports continuous improvement across the organization.

Key responsibilities

• Conduct internal audits of the Quality System to ensure compliance with QSR, GMP and ISO standards.
• Perform Good Laboratory Practice (GLP) audits as required.
• Identify non‑conformities, drive corrective and preventive actions, and execute re‑audits.
• Provide compliance advice and guidance to business units.
• Document audit findings and maintain accurate audit records.

Required profile

• Proven experience in regulatory compliance within the medical device or pharmaceutical sector.
• Strong knowledge of QSR, GMP, ISO standards and local Costa Rican regulations.
• Ability to lead audits, analyze findings and communicate effectively.
• Experience with corrective and preventive action (CAPA) processes.

Required skills

• Knowledge of Quality System Regulations (QSR) and Good Manufacturing Practices (GMP).
• Familiarity with ISO standards and Good Laboratory Practice (GLP) audit techniques.
• Proficiency in conducting corrective and preventive action (CAPA) activities.