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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

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