Job Description:
Compile technical documents to support country-specific regulatory submissions and ensure they are in a format consistent with applicable guidance documents.
Maintain data and files for future reference, especially in the event of an audit by regulators
Input and adhere to the scheduling and management of Post Market Surveillance (PMS) plans and reports.
Review product labels, marketing, and technical documentation to ensure compliance with relevant regulations and technical standards.
Participate in research of regulatory requirements and disseminate regulatory information to various departments and senior management as required.
Review product and manufacturing changes are comply with regional regulations and initiate any necessary regulatory submissions.
Assess device-related incidents/complaints for regional medical device reporting requirements and compile and submit reportable events to relevant regulatory authorities in a timely manner.
Provide regulatory guidance, ensuring correct interpretation and implementation across the departments for product design, development, evaluation, and marketing.
Assist in any other ad-hoc duties as assigned.

Job Requirements:
Bachelor’s degree in an engineering or science discipline, with a preference for biomedical engineering.
Minimum 1 year of experience in medical device regulatory affairs, quality, or engineering. Fresh graduates are also welcome.
Willingness to travel to PRC (People's Republic of China) if required.
Experience with medical devices is preferred.
Passion for documentation compilation and review, able to effectively manage multiple projects and priorities.
Good analytical skills and project management skills, effective interpersonal skills, and the ability to work effectively as a team member.
Ability to comprehend principles of engineering, physiology, and medical device use.
Proficient computer skills, including proficiency in Microsoft applications.

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.

All applications applied through our system will be delivered directly to the advertiser and privacy of personal data of the applicant will be ensured with security.

Full-time