Job Description:

• Compile and edit technical documentations to support jurisdiction-specific regulatory registration and authorization, ensure alignment with international/ national regulations, such as FDA 510(k) and EU MDD/ MDR.
• Coordinate with interdisciplinary and cross-functional teams to consolidate information for regulatory submissions, including testing protcols and reports.
• Lead and maintain company documentation for regulatory and certification purposes, ensuring compliance with relevant RA procedures. 
• Liaison with competent authorities (CA)s on audits and inspections, providing timely and appropriate response to regulatory requests.
• Providing professional advise to senior management on appropriate strategies and measures to address regulatory changes, such as Brexit, MDD transition to MDR, and MDSAP etc.
• Recommending functional departments and inter-disciplinary teams on appropriate measures to ensure compliance throughout product life cycle (PLC), such as but not limited to labeling, clinical evaluation report (CER), and post-market surveillance (PMS).
• Support marketing team, in developing regulatory messages for branding and product launch in global markets, in accordance with regulatory requirements. 
• Collaborate with and manage notified bodies to optimize conformity assessment, including technical file reviews, MDR, MDSAP, TGA, and ANISA. 
• Provide regulatory training to develop internal resources and competency in regulatory affairs. 
   

Job Requirements:

• Bachelor’s degree holder in relevant disciplines such as science or medical fields.
• Minimum 5 years’ working experience in regulated industry, preferably with Medical Device or combination products, clinical experience. 
• Knowledge in jurisdiction-specific regulations in EU, US, China, Australia, Canada, and Japan, etc.
• Proficient in Microsoft Office skills. 
• Proficient statistical analytics and strong problem solving skills.
• Ability to effectively communicate verbally and in writing in English and Chinese.
• Ability to work effectively with both internally and external parties.
• Strongly self-organised and attention to details.
• Good teamwork spirit and communication skills.
• Willing to occasionally (approx. 20%) travel to China. 
• Immediate availability is preferred.
   

Additional Information

 - To be considered for this position, you need to be legally eligible to work in Hong Kong.
 - Due to the high volume of applications, we will be contacting successful candidates only.
 - GA Health is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.