Technical Sales Engineer

Job Responsibilities:

1. Technical Consultancy & Regulatory Alignment

• Serve as the primary technical liaison between overseas manufacturers, local clinical end-users, and regulatory bodies.

• Evaluate medical device technical documentation, including risk assessments, clinical evaluation reports (CER), and declaration of conformity for CE (MDR/IVDR) and FDA (510k/PMA) submissions.

• Analyze client requirements in hospitals and medical institutions to provide technical cross-referencing and product configuration advice.

2. Strategic Business Development & Import/Export Management

• Formulate and execute business development strategies to leverage Hong Kong’s position as a premier medical device re-export and trading hub.

• Identify, vet, and onboard international distributors and institutional buyers by alignment of technical specifications.

• Manage complex, high-value tender bidding processes for public (HA) and private hospital networks in Hong Kong.

3. Cross-Border Compliance & ESG Integration

• Monitor evolving global medical device regulations to ensure all imported and re-exported products maintain continuous market access compliance.

• Advise corporate clients and manufacturing partners on sustainable procurement and ESG compliance in the medical supply chain, minimizing environmental impact in packaging and logistics.

Job Requirements:

Education: Bachelor’s degree or above in Biomedical Engineering, Biotechnology, Medical Science, International Trade, or equivalent.

Experience: Minimum of 3–5 years of progressive experience in the medical device industry, with a proven track record in technical sales, application engineering, or regulatory affairs.

Specialized Knowledge: Deep knowledge of global medical device regulatory frameworks (US FDA guidelines, EU MDR/IVDR, and ISO 13485 standards) is strictly required.

Skills: Excellent communication, negotiation, and stakeholder management skills. Ability to translate complex engineering and regulatory language into commercial value propositions.

Languages: Fluency in English and Mandarin is mandatory to manage international manufacturing principles and cross-border trade compliance.