Regulation and Certification Specialist

Role Overview

The Regulation and Certification Specialist will oversee and administer key regulatory and certification tasks necessary for the company's products and operations within industrial, medical, and consumer sectors. This position guarantees adherence to all relevant local and international regulations, including ISO standards and health and safety legislation, while handling industry-specific certifications. Acting as the primary contact for regulatory agencies and certification bodies, the specialist ensures approvals, renewals, and compliance are achieved promptly across all target markets.

Qualifications and Experience

• Bachelor’s degree in Engineering, Biomedical Science, Quality Management, or a related discipline is required.
• Possession of certifications in Regulatory Affairs or Quality Systems is advantageous.
• A experience span of 5 to 8 years in regulatory affairs or certification roles, ideally within manufacturing, healthcare, or industrial sectors.
• Profound knowledge of UAE, GCC, and global regulatory frameworks.

Key Competencies and Skills

• Strong project management capabilities with a talent for managing multiple regulatory deadlines efficiently.
• Meticulous attention to detail ensuring precision in submissions and documentation.
• Excellent ability to communicate and collaborate across departmental lines.
• A proactive approach to identifying compliance risks and delivering quick resolutions.

Technical Expertise

• Comprehensive understanding of regional and international regulatory regulations.
• Proficiency in preparing and managing technical documents including declarations of conformity and audit records.
• Acquainted with quality management frameworks such as ISO 9001, ISO 13485, plus risk management protocols.
• Capable of analyzing changes in regulations to influence product lifecycle and certification planning.

Primary Responsibilities

• Monitor and interpret regulatory mandates across UAE and international territories.
• Ensure all company offerings follow applicable laws and quality benchmarks.
• Maintain current insight into regulatory and standards updates.
• Oversee certification efforts such as ISO, FDA, CE, and other market-specific approvals.
• Coordinate comprehensive certification undertakings, engaging with notified bodies and auditors.
• Compile, maintain, and assure the quality of regulatory submissions and technical files.
• Manage renewal schedules for certifications and registrations.
• Facilitate collaboration with R&D, Quality, Manufacturing, and other divisions to uphold regulatory compliance.
• Provide regulatory support to clients, partners, and internal teams.
• Act as the company’s representative in dealings with government and regulatory organizations.
• Propose and execute enhancements in regulatory compliance processes and workflows.
• Assist in internal and external auditing activities and raise awareness about certification requirements within the organization.

Communication and Collaboration

• Engage internally with Quality, Legal, Research & Development, and Operations teams.
• Coordinate externally with certification entities, government agencies, and regulatory institutions.