招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
JOB Title: Engineer, Regulatory Affair (RA) & EHS
JOB Summary
For RA, develops and implements strategies for the timely approval of regulatory applications. Achieve required assigned division or product line regulatory registrations and certifications for products manufactured and sold. Assure compliance to the policies of worldwide regulatory agencies by establishing procedures for division or product as required.
For EHS, implements effective safety and environmental guidelines, policies, and programs that will maintain a safe workplace and environmental objectives. Maintain compliance with state and local ordinances and regulations.
DUTIES:
Regulatory Affair (RA)
l Develops and implements strategies for the timely approval of regulatory applications. Provide timely updates to management on changes in regulatory requirements.
l Ensure that regulatory authorities' requirements are met for products engineered, manufactured or sold by assigned division or product line.
l Along with project engineer, ensures that each product complies with local, regional, and/or national registration, safety, and other required approvals before product is delivered to the customer.
l Develop changes as required for labeling, manufacturing, marketing, engineering and clinical protocols for regulatory compliance.
l Ensure that appropriate tracking and control systems exist.
EHS:
l Maintain company compliance with all appropriate governmental regulations. Develops and updates company safety and environmental policy guidelines, contingency plans, and emergency procedures as required.
l Tracks corporate data and reports on hazardous chemicals and emissions for air, waste stream, and waste water as required by regulatory agencies. Represent the corporation during outside audits.
l In support of safety and environmental objectives, identifies appropriate sources of information regarding standards, codes, guidelines, or specifications established by various professional and technical organizations and associations. Maintain a high degree of professionalism and technical expertise in environment, health and safety management.
l Develops and implements policies and training programs that incorporate company safety and environment objectives as a line organizational responsibility.
l Coordinate the semi-annual/annual certification of safety equipment and systems, including vendor selection.
l Standardize safety equipment, coordinate company safety glasses and first aid programs.
EDUCATION AND EXPERIENCE:
l Bachelor in a technical discipline or equivalent,
l Minimum 3 years working experience in regulatory affair (RA) management.
l Strong self-motivator and be able to handle the work independently
l Positive and Energetic , be able to work under pressure and handle multi-tasks if necessary
l Fluency in Mandarin and English
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