Regulatory Affairs Specialist
GA Health Company Limited
- Company Industries:Others
Job Information
- Post Date:2024-10-05
- Location:Sha Tin District
- Employment Type:Full time
- Others:Dynamic and friendly working culture
Flexible working hours and career development - Job Function:Quality Assurance Control
- Benefits:13th month double pay salary guaranteed
Job Description
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.
Company Info
GA Health Company Limited
Contact
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