REGULATION & CERTIFICATION SPECIALIST @ TALENTONE
TalentOne is seeking a dedicated Regulation & Certification Specialist to join their team in Abu Dhabi. In this role, you will be responsible for leading regulatory compliance across the UAE, GCC, and international markets. You will play a pivotal part in ensuring that products meet rigorous global standards, including ISO, CE, and FDA requirements, which are essential for industrial, medical, and consumer sectors. Your work will directly impact market access and the overall growth of the organization.
The successful candidate will manage the end-to-end certification process, from initial submission to renewal. This includes coordinating with auditors and notified bodies, maintaining meticulous technical documentation, and partnering with internal departments like R&D and Legal to ensure seamless operations. You will also be tasked with driving process improvements within the compliance framework and maintaining audit readiness at all times. This is an excellent opportunity for a professional with deep expertise in regulatory affairs to thrive in an innovative environment.
The successful candidate will manage the end-to-end certification process, from initial submission to renewal. This includes coordinating with auditors and notified bodies, maintaining meticulous technical documentation, and partnering with internal departments like R&D and Legal to ensure seamless operations. You will also be tasked with driving process improvements within the compliance framework and maintaining audit readiness at all times. This is an excellent opportunity for a professional with deep expertise in regulatory affairs to thrive in an innovative environment.
Key Requirements
Bachelor’s degree in Engineering, Biomedical Science, or a related field.
5–8 years of professional experience in regulatory affairs or certification roles.
Comprehensive knowledge of UAE/GCC and international regulatory standards.
Hands-on experience with ISO standards, specifically ISO 9001 and ISO 13485.
Proven track record in managing CE marking and FDA approval processes.
Experience coordinating directly with notified bodies, auditors, and regulatory authorities.
Ability to prepare and maintain detailed technical documentation and compliance records.
Strong skills in tracking certification renewals, audits, and regulatory timelines.
Excellent communication and stakeholder management skills for cross-functional collaboration.
Ability to drive process improvements and strengthen internal compliance frameworks.