Prepare and maintain Technical Files for CE marking, ISO standards, or product certification processes including design documents, risk assessments, test reports, and user manuals.
Draft and update the Declaration of Conformity (DoC) and related compliance statements.
Liaise with product design, engineering, and quality teams to collect required technical data.
Coordinate with external testing laboratories and notified bodies during product certification.
Track changes in EU directives, harmonized standards, and regulatory requirements.
Ensure proper version control and archiving of compliance documents.
Support internal and external audits related to CE marking and product compliance.
Assist in training staff on document management procedures and ISO requirements.
Maintain a clear and accessible document filing system (physical and electronic).
Requirements
Diploma/Degree in Engineering, Quality, Regulatory Affairs, or related discipline.
Experience with CE marking, ISO standards, or product certification processes is an advantage.
Strong technical writing and documentation skills.
Familiarity with EU directives , EMC Directive, Machinery Directive, or similar (depending on product type).
Attention to detail and strong organizational skills.
Good communication skills to coordinate with engineers, QA, and external certifying bodies.
