Regulation And Certification Specialist

TalentOne; Abu Dhabi; On-site; AED 180,000 - 300,000; Full time

Job summary

TalentOne is seeking a Regulation and Certification Specialist to oversee regulatory and certification activities across industrial, medical, and consumer segments in the UAE and international markets. The role ensures compliance with ISO standards, health and safety laws, and industry certifications, serving as a liaison with authorities and certification bodies.

The specialist will manage timely approvals, renewals, and submissions, coordinating with R&D, Quality, and Manufacturing to maintain

Qualifications

• Bachelor’s degree in Engineering, Biomedical Science, QualityManagement, or related field.
• Certification in Regulatory Affairs or Quality Systems ispreferred.
• 5–8 years of experience in regulatory affairs or certificationroles, preferably in manufacturing, healthcare, or industrial sectors.
• Strongunderstanding of UAE, GCC, and international regulatory frameworks

Responsibilities

• Monitor UAE and international regulatory requirements.
• Coordinate certification processes including ISO, FDA, CE, and other market-specific approvals.
• Prepare documentation and responses for audits and certification applications.
• Collaborate with R&D, Quality, and Manufacturing to ensure regulatory alignment.
• Track renewal timelines for all certifications and registrations.
• Support internal and external audits and liaise with regulatory authorities.

Skills

Project management

Attention to detail

Stakeholder engagement

Regulatory forecasting

Problem solving

Education

Bachelor’s degree in Engineering or related field

Certification in Regulatory Affairs or Quality Systems

Job description

Job Description

Regulationand certification specialist

Job Purpose

To support and manage regulatory andcertification activities required for Company products and operations across industrial, medical, and consumer segments. The role ensures that all offeringscomply with applicable local and international regulations, including ISOstandards, health and safety laws, and specific industry certifications. Thespecialist will act as a key liaison with regulatory authorities andcertification bodies, ensuring timely approvals, renewals, and complianceacross all relevant markets.

Qualifications, Experience, Knowledge & Skills

Qualifications:

• Bachelor’s degree in Engineering, Biomedical Science, QualityManagement, or related field.
• Certification in Regulatory Affairs or Quality Systems ispreferred.

Experience:

• 5–8 years of experience in regulatory affairs or certificationroles, preferably in manufacturing, healthcare, or industrial sectors.
• Strongunderstanding of UAE, GCC, and international regulatory frameworks

Skills

• Strong project management skills with the ability to handlemultiple regulatory timelines.
• High attention to detail and accuracy in regulatory submissions anddocumentation.
• Excellent interpersonal and stakeholder engagement abilities acrossdepartments.
• Proactive mindset with the ability to anticipate compliance risksand resolve issues swiftly.

Technical Competencies

• In-depth understanding of regional and international regulatoryframeworks.
• Expertise in preparing and maintaining technical files,declarations of conformity, and audit materials.
• Familiarity with quality management systems such as ISO 9001, ISO13485, and risk management standards.
• Ability to analyze regulatory updates and apply them to productlifecycle and certification strategy.

Requirements

Regulatory Compliance

• Monitor and interpret regulatory requirements in the UAE andinternational markets.
• Ensure company practices and products adhere to current regulationsand quality standards.
• Maintain up-to-date knowledge of changes in applicable laws andstandards.

Certification Management

• Manage certification processes including ISO, FDA, CE, and othermarket-specific approvals.
• Coordinate product and system certifications like ISO and otherrelevant marks.
• Liaise with notified bodies and third-party auditors.
• Prepare documentation and responses for audits and certificationapplications.

Documentation and Submissions

• Compile and maintain technical files, declarations, and regulatorysubmissions.
• Ensure accuracy and completeness of compliance documentation.
• Track renewal timelines for all certifications and registrations.

Stakeholder Engagement

• Work with cross-functional teams including R&D, Quality, andManufacturing to ensure regulatory alignment.
• Support clients, partners, and internal teams with regulatoryqueries and documentation requests.
• Represent SINDAN in interactions with government entities andregulatory authorities.

Process Improvement

• Recommend and implement improvements in compliance workflows.
• Assist in building internal awareness of regulatory andcertification requirements.
• Support internal and external audits.

Communications and Working Relationships

• Internal collaboration with Quality, Legal, R&D, and Operationsteams.
• External coordinationwith certification bodies, government entities, and regulatory agencies