Spring Professional is an international firm specializing in the recruitment of middle to senior level positions. With 9 offices in Asia including Hong Kong, Singapore, Taiwan, Korea, Thailand, Malaysia, Shanghai, Beijing and Japan. Our expertise in Hong Kong includes:Property & ConstructionInformation...

Spring Professional is an international firm specializing in the recruitment of middle to senior level positions. With 9 offices in Asia including Hong Kong, Singapore, Taiwan, Korea, Thailand, Malaysia, Shanghai, Beijing and Japan. Our expertise in Hong Kong includes:

  • Property & Construction
  • Information technology
  • Engineering & Supply Chain
  • Corporate Services – Sales & Marketing, Accounting & Finance, HR

Spring Professional is a wholly-owned subsidiary of the Adecco Group. Based in Zurich, Switzerland, Adecco is the world’s leading provider of HR solutions. With more than 33,000 FTE employees and a network of over 5,500 branches, in over 60 countries and territories around the world, the Adecco Group offers a wide variety of services, connecting over 700,000 associates with more than 100,000 clients every day.

Regulatory Affairs Manager (35-60k)

Job level Middle
Work exp Minimum 5 Years
Education Bachelor Degree
Location
Hong Kong Island
Employment type Full Time
Benefits 5-day week, Dental plan, Insurance plan, Medical plan, Performance bonus, Shuttle bus
Industry Trading / Merchandising / Wholesale
Job function Legal / Professional Services > Legal & Compliance
Merchandising / Purchasing > Purchasing / Procurement / Sourcing
Quality Control / Quality Assurance > Testing
Published On 23/05/2019

About the Client
My client is a Medical Device company and now looking for high caliber individuals to join the position of Regulatory Affairs Manager.

About the Role

  • Develop product requirement in accordance with applicable laws, regulations and standards, follow up product testing and clinical trial
  • Internal coordination with R&D, Supply Chain, Manufacturing and Quality teams
  • Responsible for NPI and developing whole regulatory procedure from testing to submission within framework
  • Evaluate and inspect those promotional material to ensure the label and quality of the products are fit in accordance with local regulations and corporate standards.
  • Liaise and maintain relationship with local government authorities and regulatory agencies 
  • Support the establishment of clinical framework for medical endoscopic products, improve registration related documents;


About the Candidate

  • Degree or above in engineering, scientific or medical;
  • 5 years experience in medical device company with proven record of product registration
  • Solid understand and experience in China and Europe market
  • Familiar with clinical trial procedures and compliance requirement and medical device quality management system
  • Strong communication skills, independent, able to work under pressure
  • China travelling is required