Regulatory Affairs Specialist | Quality Compliance

Role Overview

Employment and Level

• Employment type is full-time.
• The description identifies the role as mid-level.

Regulatory Responsibilities

• Monitor regulatory requirements, standards, guidelines, and industry developments.
• Support submissions, registrations, renewals, amendments, and product approvals.
• Maintain regulatory records, licenses, certificates, approvals, and submission packages.
• Communicate regulatory updates and compliance requirements to internal departments.

Quality and Audit Responsibilities

• Support quality management systems and monitor compliance with policies, procedures, and standards.
• Conduct compliance reviews, internal assessments, quality checks, audits, and inspections.
• Track CAPA and support investigations into deviations, non-conformances, complaints, and quality incidents.
• Coordinate change control, document control, corrective actions, and risk mitigation.

Stakeholder and Reporting Duties

• Liaise with regulatory authorities, certification bodies, auditors, consultants, suppliers, and external partners.
• Provide compliance guidance to product development, manufacturing, operations, procurement, and commercial teams.
• Maintain regulatory databases and prepare regular quality and compliance reports.

Required Qualifications

• Diploma or bachelor's degree in a relevant regulatory, quality, life sciences, engineering, healthcare, or related field.
• Experience in regulatory affairs, quality assurance, compliance, or a regulated industry.
• Knowledge of regulatory frameworks, quality systems, compliance principles, and regulatory documentation.
• Experience supporting audits or inspections and managing CAPA, deviations, change control, and risk assessment.
• Strong communication, organization, analytical, documentation, and time-management skills.
• Proficiency in Microsoft Office, document-management systems, and quality-management software.

Preferred Qualifications

• Familiarity with ISO 9001, ISO 13485, GMP, GxP, or other relevant regulatory frameworks is advantageous.
• Professional certification in regulatory affairs, quality management, compliance, or auditing is advantageous.
• Experience in pharmaceuticals, medical devices, biotechnology, healthcare, food, cosmetics, manufacturing, or another regulated industry is a plus.

What the Employer Offers

• Competitive salary and employee benefits are offered.
• The role includes training, certification support, cross-functional exposure, and career development opportunities.
• The employer describes opportunities to participate in quality improvement and regulatory transformation projects.