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Company
TRINITY BIZ VENTURE PTE. LTD.
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Job Description
Key Responsibilities
- 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.
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