Regulation and certification specialist

1.Regulation and certification specialist

Qualifications:

·       Bachelor’s degree in Engineering, Biomedical Science, Quality Management, or related field.

·       Certification in Regulatory Affairs or Quality Systems is preferred.

Experience:

·       5–8 years of experience in regulatory affairs or certification roles, preferably in manufacturing, healthcare, or industrial sectors.

·       Strong understanding of UAE, GCC, and international regulatory frameworks

·       Strong project management skills with the ability to handle multiple regulatory timelines.

·       High attention to detail and accuracy in regulatory submissions and documentation.

·       Excellent interpersonal and stakeholder engagement abilities across departments.

·       Proactive mindset with the ability to anticipate compliance risks and resolve issues swiftly.

 TECHNICAL COMPETENCIES

·       In-depth understanding of regional and international regulatory frameworks.

·       Expertise in preparing and maintaining technical files, declarations of conformity, and audit materials.

·       Familiarity with quality management systems such as ISO 9001, ISO 13485, and risk management standards.

·       Ability to analyze regulatory updates and apply them to product lifecycle and certification strategy.

1.     KEY ACCOUNTABILITIES

Job Specific Accountabilities

Regulatory Compliance

·       Monitor and interpret regulatory requirements in the UAE and international markets.

·       Ensure company practices and products adhere to current regulations and quality standards.

·       Maintain up-to-date knowledge of changes in applicable laws and standards.

Certification Management

·       Manage certification processes including ISO, FDA, CE, and other market-specific approvals.

·       Coordinate product and system certifications like ISO and other relevant marks.

·       Liaise with notified bodies and third-party auditors.

·       Prepare documentation and responses for audits and certification applications.

Documentation and Submissions

·       Compile and maintain technical files, declarations, and regulatory submissions.

·       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, and Manufacturing to ensure regulatory alignment.

·       Support clients, partners, and internal teams with regulatory queries and documentation requests.

·       Represent SINDAN in interactions with government entities and regulatory authorities.

Process Improvement

·       Recommend and implement improvements in compliance workflows.

·       Assist in building internal awareness of regulatory and certification requirements.

·       Support internal and external audits.

2.     COMMUNICATIONS AND WORKING RELATIONSHIPS

·       Internal collaboration with Quality, Legal, R&D, and Operations teams.