Medical Device Registration and Approval Expert, APAC

5 days ago


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

About the Team


You will join a dynamic team at Accuray Asia Ltd, dedicated to delivering innovative medical solutions to patients across the Asia Pacific region. Our team operates under a collaborative culture that emphasizes open communication, respect, and a passion for excellence.


This role offers an exciting opportunity to leverage your expertise in Regulatory Affairs and drive business growth in a fast-paced environment. You will work closely with colleagues from diverse backgrounds, fostering a learning environment that promotes skill development and professional growth.


Key Responsibilities



  • Liaise with cross-functional teams to develop and implement regulatory strategies that align with business objectives.
  • Maintain comprehensive knowledge of regional regulations and standards, ensuring seamless market access for Accuray products.
  • Develop and lead workshops, training sessions, and educational programs to enhance team skills and stay current with evolving regulatory landscapes.
  • Provide guidance and support to colleagues on regulatory matters, promoting best practices and consistent compliance with regional requirements.
  • Communicate regulatory updates, changes, and requirements to stakeholders, ensuring timely information exchange and minimizing disruptions to operations.
  • Prioritize tasks, manage multiple projects simultaneously, and maintain high-quality results while meeting deadlines.

Requirements



  • A degree in a field such as law, life sciences, or business.
  • A minimum of 5 years' experience in Regulatory Affairs within the medical devices industry, preferably with international exposure.
  • Proven track record of driving business growth through strategic regulatory planning and execution.
  • Expertise in regional regulations and standards applicable to medical device market clearance.
  • Exceptional leadership and interpersonal skills; ability to motivate and guide cross-functional teams.
  • Ability to think critically, analyze complex data, and make informed decisions.


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