Medical Device Regulatory Clearance Expert

4 days ago


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

Are you a detail-oriented professional with a passion for regulatory affairs? Do you have a strong background in medical devices and a proven track record of success in the Asia Pacific region?

About the Role:

  • This is a full-time position that requires a high level of autonomy and independence.
  • The successful candidate will be responsible for preparing and submitting regulatory applications for medical device market approvals.
  • They will also develop and maintain knowledge of local regulations and standards applicable to medical device market clearance.

Responsibilities:

  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Analyze and interpret regulatory data to inform business decisions.
  • Communicate effectively with regulatory agencies and other stakeholders.

Qualifications:

  • Bachelor's degree in a technical field, such as engineering or life sciences.
  • Minimum 3 years of experience in regulatory affairs, with a focus on medical devices.
  • Strong understanding of Asia Pacific regulations and standards.
  • Excellent communication and project management skills.

We are an equal opportunities employer and welcome applications from diverse candidates.



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