Regional Regulatory Affairs Manager

Regional Regulatory Affairs Manager based in Malaysia

Your new company
Our client is a Beijing based company, national high-tech enterprise with more than 10 years of experience in the molecular diagnosis industry. It focuses on the field of point-of-care testing (POCT), and is especially good at nucleic acid detection technology for pathogenic microorganisms. It is an academician expert workstation, a national infectious disease It is the undertaking unit of major special projects, the undertaking unit of the "Torch Plan" industrialisation demonstration project of the Ministry of Science and Technology, and the undertaking unit of the training project of the National Health Commission. The company has always practiced the vision of "allowing everyone to benefit from molecular diagnostics", allowing molecular diagnostics to truly come to the scene and opening the road to molecular testing that is fast, accurate, simple, portable and beneficial to the people.

Your new role
· Support the development and implementation of strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, and marketing applications
· Ensure timely preparation of organised and scientifically valid applications; provide expertise in translating regulatory requirements into practical, workable solutions
· Support the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation of submissions to achieve timely and cost-effective clearance/approval
· Provide information for maintaining registrations and listings
· Monitor and assess Regulatory developments (e.g., Federal Register publication/notices, FDA guidelines, etc.) and change management related to the Company’s products
· Review product labelling to ensure conformance with regulatory requirements and/or approved product claims
· Negotiate with regulatory authorities to resolve questions/issues that arise during the product life-cycle
· Write and implement appropriate procedures and processes as needed

What you'll need to succeed
· A minimum of 5 years of regulatory affairs experience in the molecular diagnostic industry and familiar with PCR technology
· Knowledge of IVDD and IVDR requirements
· Experience preparing technical documents and submission dossiers
· IVD experience is strongly preferred.
· Broad knowledge of and experience with US, EU, and Rest-of-World medical device registration processes
· Regulatory Affairs certificate from RAPS or other organisation · 510(k) submission experience

What you'll get in return

In return, you'll be part of an organisation who values their employees. You will have a structured career growth and plenty of developmental opportunities. You will also be compensated with attractive remuneration package

What you need to do now
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Job Type
Working Pattern
Regulatory Affairs

Talk to a consultant

Talk to Sudan Peng, the specialist consultant managing this position, located in London-City
4th Floor, 107 Cheapside

Telephone: 02034650158