Asia Pacific Medical Device Regulatory Compliance Specialist

2 days ago


Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

About the Role


This exciting opportunity exists within the Accuray Asia Ltd team, where you will contribute to ensuring the smooth launch of medical devices in the Asia Pacific market. As a key member of our Regulatory Affairs team, you will work closely with cross-functional teams to guarantee compliance with regional regulatory requirements.


Your primary responsibilities will include preparing and submitting regulatory applications, managing Asia Pacific Technical Files, and collaborating with various stakeholders to achieve regulatory goals.


Key Responsibilities



  • Develop and maintain in-depth knowledge of Asia Pacific regulations and standards relevant to medical device market clearance.
  • Prepare and submit regulatory applications, including Technical Files, to ensure compliance with regional requirements.
  • Collaborate with research and development teams to ensure clinical research and clinical evaluations meet necessary regulatory standards.
  • Conduct audits and assessments to identify areas for improvement and implement corrective actions.
  • Compile and review documentation for submission to regulatory authorities, customers, and other stakeholders.
  • Develop and maintain effective relationships with regulatory agencies and industry partners to ensure successful market access.
  • Participate in training and education programs to enhance skills and stay up-to-date with changing regulatory landscapes.

Requirements



  • A degree in a field such as engineering, life sciences, or business.
  • A minimum of 3 years' experience in Regulatory Affairs within the medical devices industry.
  • Proven track record of successfully launching medical devices in the Asia Pacific market.
  • Strong understanding of regional regulations and standards applicable to medical device market clearance.
  • Excellent communication and interpersonal skills; ability to work effectively in a team environment.
  • Strong analytical and problem-solving skills; ability to interpret complex data and make informed decisions.


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