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Certification Engineer
Fda · Zhangjiagang, Jiangsu, China
About The Role
Key Responsibilities
- Product Certification & Regulatory Compliance
- a) Manage product certification processes for domestic and international markets, including CE, UL, CSA, CCC, KCs, UKCA, AS/NZS and other applicable approvals.
- b) Identify, interpret, and monitor applicable regulations, directives, standards, and certification requirements for target markets.
- c) Ensure products comply with relevant regulatory, safety, environmental, and product conformity requirements.
- d) Coordinate certification testing with accredited laboratories, certification bodies, notified bodies, and regulatory agencies.
- e) Maintain product certification records, technical files, compliance dossiers, and audit-ready documentation.
- New Product Development & Engineering Support
- a) Participate in product development and design reviews to identify certification and regulatory requirements at an early stage.
- b) Provide guidance to engineering teams on compliance, certification, product safety, functional safety, and regulatory requirements.
- c) Review electrical, mechanical, control system, and engineering change designs to assess compliance and certification impact.
- d) Support product validation, verification, testing, and corrective actions when certification or test issues are identified.
- Regulatory Management & Documentation
- a) Serve as the primary contact for regulatory authorities, certification organizations, testing agencies, and external laboratories.
- b) Prepare and submit certification applications, technical documentation, and supporting materials.
- c) Manage certification renewals, surveillance audits, product type approvals, and homologation activities.
- d) Ensure compliance documentation is complete, current, controlled, and ready for internal and external review.
- Cross-Functional Collaboration
- a) Work closely with Engineering, Quality, Manufacturing, Supply Chain, Product Management, and global teams to resolve certification and compliance-related issues.
- b) Support manufacturing and production teams in maintaining certified product configurations and compliant components or materials.
- c) Liaise with global teams to align compliance strategies and regulatory requirements across different regions.
- d) Provide training and technical guidance on regulatory and certification requirements to internal stakeholders.
- Audit, Risk Management & Continuous Improvement
- a) Support internal and external compliance audits, inspections, and certification reviews.
- b) Identify certification risks, investigate non-conformities, and drive corrective and preventive actions.
- c) Monitor regulatory changes and assess their impact on existing and new products.
- d) Develop and improve certification processes, reduce certification lead time, and support continuous improvement initiatives.
Qualifications & Requirements
- Education
Bachelor’s degree or above in Mechanical Engineering, Electrical Engineering, Mechatronics, Industrial Engineering, Quality Engineering, or related discipline.
- Experience
- a) Minimum 3 to 5 years of experience in product certification, regulatory compliance, product safety, quality, or engineering within manufacturing industries.
- b) Experience working with certification bodies, laboratories, notified bodies, and regulatory agencies.
- c) Experience supporting product development, engineering change processes, testing, validation, and certification activities.
- d) Experience in heavy equipment, cranes, industrial equipment, machinery, automation systems, automotive, or manufacturing environments is preferred.
- Technical Knowledge
Knowledge of one or more of the following areas is preferred
- a) China Compulsory Certification (CCC).
- b) CE marking process and EU directives.
- c) UKCA, UL, CSA, KCs, AS/NZS, EAC or other global certification systems.
- d) Machinery Safety Standards, Low Voltage Directive, EMC, RoHS and REACH requirements.
- e) IEC/EN standards, functional safety principles, ISO 13849, IEC 62061, and EN 60204-1.
- f) Electrical safety, structural and mechanical testing, environmental regulations, and product compliance documentation.
- g) Modbus, PLC systems, or industrial control systems is a plus.
- Skills & Competencies
- a) Strong regulatory awareness and compliance mindset.
- b) Strong analytical, problem-solving, and risk-based thinking skills.
- c) Good project management and coordination skills.
- d) Ability to interpret complex regulations and translate them into engineering requirements.
- e) Excellent technical documentation and report-writing skills.
- f) Effective communication and stakeholder management skills with cross-functional and international teams.
- g) Ability to manage multiple certification projects simultaneously with attention to detail and accuracy.
- h) Fluent Mandarin required; English communication skills preferred.
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