The skill sets required for an occupation 10 years ago may not be the same today. Changes in regulations are one of the key factors that would trigger a change in skill sets so as to remain relevant and be in compliance with the regulations. In this article, we will be talking about the changes Regulatory Affairs candidates should take note of.

Critical Change of Regulatory Affairs Talent Market under China Regulation Revolution Environment

In 2014 and 2018, there are changes in regulations to how medical devices are to be registered in China. Medical devices are classified into 3 classes, depending on the risk presented to the users. With Class I being the lowest risk, and Class III being the highest.

Class II and Class III medical devices are required to undergo a registration test. It will be conducted by medical device testing institutes before they can be registered. The registration test will be carried out according to relevant product technical requirements. The production of the registration test samples shall accord with the requirements of the medical device quality management system. Clinical trials or registration can only be conducted after the registration test certifies that the samples are qualified.

For devices requiring clinical trials, the clinical evaluation data to be submitted will include the clinical trial protocols and reports. These documents will be produced during the clinical evaluation conducted by the registration or recording applicant.

Based on the change, new requirements are expected from regulatory affairs candidates

Stronger Technical Background. Ability to understand the clinical trial reports will be necessary.
Differentiating between Active and Passive medical devices. It will not be easy for the RA candidate to transit between active and passive medical device work as compared to before due to the changes.
Clinical Report Preparation. This requires the RA candidate to have a good command of English.

With Kingfisher’s experience on RA talent hiring and our Consultants’ engagement with many senior leaders in RA & QA fields, 5 key competencies that will be up and coming for RA talent development will be:

Strong Technical Background. Changing medical device market will require RA team leaders and individuals to have strong technical background and to be more specialized and professional in their work.
Broader job responsibilities for RA talents due to changes in regulations to cover the clinical trials process including clinical trial report preparation.
Deeper understanding of the company’s business, short- and long-term goals by engaging in more cross-function communication
Engage in more strategic thinking activities instead of implementation
Increased daily cooperation and connection with global/headquarter colleagues
Article written by Ellen Lan, Branch Manager of Kingfisher Beijing Office. Ellen has over 10 years of executive search experiences focusing on Healthcare, Consumer, Industrial and ICT sectors across North China and APAC region.

Find Ellen on LinkedIn! Kingfisher Recruitment Group is a global provider of total recruitment solutions. We help clients design people strategies, attract and develop talents worldwide across Healthcare & Life Sciences, Professional Services, Technology, Retail & Consumer, Manufacturing, Automotive, Property & Construction and Engineering industries. Let us know if you are seeking for opportunities or looking for talents within these industries.