Regulatory Affairs Manager

Regulatory Affairs Manager

NISI (HK) Limited, a premier surgical robotic start-up based in Hong Kong, is looking for high-caliber candidates to make significant contributions to their product development and manufacturing roadmap.

Job Description

  • Responsible for medical device registration in mainland China and EU, not limited to product testing, clinical trial, product registration submission, ensure that products are registered on schedule;
  • Draft product requirements in accordance with applicable laws, regulations and standards, follow up product testing and clinical trial;
  • Support the establishment of clinical framework for medical endoscopic products, improve registration related documents;
  • First point of contact and maintain good business relation with regulatory agencies such as test lab, clinical trial centre, registration authority;
  • Coordinate project management of endoscopic devices, maintain smooth and effective communication among R&D, purchase, production and quality teams within the company.

Candidates are expected to fulfill most of the following requirements:

  • Degree in electrical, biomedical, material and mechatronic engineering;
  • Minimal 5 years practical experience in active medical device registration and project management; priority will be given those who have practical experience in medical endoscopic device or surgical robotic system
  • Sound knowledge in medical device regulation, technical standard, familiar with clinical trial procedures and compliance requirement;
  • Excellent in both Chinese and English communication, familiar with medical device quality management system;
  • Effective communication skills, strong capability to analyze and solve problems;
  • Occasional travel to China.

Primary Working Location:

  • Cyberport, Hong Kong

Salary will be commensurate with qualifications and experience. To apply, please send your resume, including your current and expected salary, and the earliest availability to

All personal data are collected for recruitment purpose only.

January 2, 2019

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