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 jobs@nisi.hk.

All personal data are collected for recruitment purpose only.

January 2, 2019

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