Registration Engineer

Job Responsibilities:

1. Prepare and submit product registration applications in compliance with medical device regulations and product registration processes.

2. Develop technical documentation and application materials for medical device products, ensuring product samples are sent for testing.

3. Organize and coordinate on-site assessments for medical device registration systems.

5. Organize training and guidance on registration-related knowledge and skills within the company.

6. Communicate and liaise with regulatory authorities for updates and information exchange.

7. Perform other tasks as assigned by senior management.

Job Requirements:

1. Three-year college degree or higher.

2. Indepth knowledge of the medical device registration process and relevant regulations, with proven experience in successfully registering Class II and Class III products.

3. Strong technical writing skills and the ability to independently prepare regulatory documents.

4. Excellent logical thinking and communication skills.

Purchasing Engineer

Job Responsibilities:

1. Oversee the procurement of R&D materials, including sheet metal hardware, machining components, plastic tubing, and packaging materials.

2. Manage the purchase of jigs and fixtures, including custom-made production tools.

3. Identify and develop new suppliers, conduct supplier audits, and confirm samples. Maintain and foster strong relationships with existing qualified suppliers.

4. Address delivery and quality issues.

5. Handle purchasing reconciliations, payments, and invoices.

6. Gather and organize supplier information and material qualifications to meet quality and regulatory requirements.

Job Requirements:

1. Minimum 3 years of purchasing experience in the medical device manufacturing industry. Familiar with supply chain processes, supplier development, assessment, and price comparison and negotiation.

2. Engineering background with the ability to interpret technical documents and drawings.

3. Strong communication and coordination skills, resilience, and strong teamwork abilities.

4. Proficiency in office software, ERP systems (Kingdee), and OA systems.