Technical Support

Key Responsibilities

You will be responsible for a diverse set of tasks across regulatory compliance and commercial support, including:

1. Product Registration & Regulatory Compliance

• Prepare and compile comprehensive technical documentation and regulatory submissions for product registration and certification with local health authorities (e.g., BPMO, HSA, TGA, etc.).

• Coordinate with global regulatory teams, manufacturers, and third-party consultants to support new product approvals and renewals.

• Maintain expert, up-to-date knowledge of global medical device regulations and standards (e.g., ISO 13485, MDR, IVDR).

• Support post-market surveillance, vigilance reporting, and product recall procedures as required.

  
  

2. Technical Marketing & Commercial Support

• Act as the technical expert for the marketing team, providing accurate input for product brochures, presentations, and promotional materials.

• Develop and deliver product demonstrations, technical seminars, and workshops for customers, distributors, and internal sales teams.

• Provide technical training and product knowledge support to sales representatives and channel partners.

• Participate in trade shows, exhibitions, and conferences to effectively support product promotion and technical inquiries.

• Liaise with R&D and Quality teams to communicate valuable field feedback, supporting continuous product improvement.

  
  

3. Cross-Functional Collaboration & Quality

• Liaise between regulatory, marketing, sales, and engineering teams to ensure a seamless product launch and lifecycle management process.

• Support quality management initiatives, audits, and corrective/preventive action processes.

• Collaborate with suppliers and manufacturing partners to resolve product quality or compliance issues.

  
  

QualificationsEducation & Experience

• Bachelor’s degree in Biomedical Engineering, Medical Technology, Electrical Engineering, or a closely related technical field.

• Minimum of 1-2 years of experience in medical device support, regulatory affairs, or technical marketing.

• Proven experience with medical device registration and compliance documentation is highly preferred.

  
  

Skills & Competencies

• Strong understanding of medical device regulatory frameworks (e.g., FDA, CE, ISO 13485).

• Excellent technical writing, documentation, and presentation skills.

• Proficiency in Microsoft Office and experience with document control systems.

• Strong interpersonal and communication skills to work effectively with cross-functional teams.

• Analytical and problem-solving mindset with meticulous attention to detail.

• Ability to manage multiple projects and meet deadlines in a fast-paced environment.

• Language Skills: Proficiency in English is required; ability in Chinese is highly preferred to liaise with regional partners.