ob Summary

United Medical Industries Limited Co. LLC (UNIMED) is seeking an experienced Quality Assurance Manager & Person Responsible for Regulatory Compliance (PRRC) to lead and oversee the company’s Quality Assurance, Quality Control, and Regulatory Compliance activities.

The successful candidate will be responsible for maintaining and continuously improving the Quality Management System, ensuring regulatory compliance, supporting product quality and release, and coordinating with internal departments, certification bodies, and regulatory authorities.

Key Requirements

• Bachelor’s degree in Science, Pharmacy, Biomedical Engineering, or a related field.
• Minimum 5 years of relevant industry experience, with at least 2 years of experience in Quality Assurance.
• Experience in medical device manufacturing is highly preferred. Experience in pharmaceutical or food manufacturing will also be considered.
• Strong knowledge of EU MDR, US FDA, SFDA, MOH, and MENA regulatory requirements.
• Good knowledge of ISO 13485:2016 and ISO 9001:2015.
• Training/certification in Lead Auditor and/or Internal Auditor is preferred.
• Knowledge of CE Marking and Good Manufacturing Practices (GMP).
• Experience in technical documentation, quality reports, regulatory documentation, and post-market surveillance.
• Strong leadership, communication, analytical, research, documentation, and problem-solving skills.
• English is mandatory; Arabic is an advantage.

Key Responsibilities

• Develop, implement, monitor, and continuously improve the company’s Quality Management System.
• Ensure quality policies, procedures, work instructions, and quality objectives are effectively implemented.
• Ensure medical devices meet applicable quality and regulatory requirements before release.
• Ensure technical documentation and EU Declaration of Conformity are prepared and maintained.
• Manage post-market surveillance, vigilance, customer complaints, and regulatory reporting.
• Plan and supervise internal audits and participate in external and certification audits.
• Review audit findings and ensure corrective actions and non-conformities are properly addressed.
• Review batch records and support the release of finished products.
• Coordinate with regulatory authorities, certification bodies, Production, QC, Stores, Sales, suppliers, and other departments.
• Lead and supervise the QA/QC and Regulatory Affairs functions.
• Identify training needs and promote continuous improvement and quality awareness across the organization.

Preferred Training & Certifications

• ISO 13485:2016 / ISO 9001:2015
• Lead Auditor / Internal Auditor
• CE Marking / European Conformity
• Good Manufacturing Practices (GMP)
• EU MDR / Medical Device Regulatory Compliance

How to Apply

Interested candidates who meet the above requirements are invited to apply through Indeed or send their updated CV to:

recruitment@unimed.co.ae

Subject: Application – Quality Assurance Manager & PRRC

Only candidates meeting the required qualifications and experience will be considered.

Pay: AED15,000.00 - AED20,000.00 per month

Work Location: In person