Head of Regulatory and Quality Assurance - APAC
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Salary Negotiable
Location Beijing
FULL_TIMEConsultant Echo Yang
JobRef 1197440/001
Date posted 30 December 2022
beijing Healthcare/qa-ra 2022-12-30 2023-02-28 pharmaceuticals Beijing CN Robert Walters https://www.robertwalters.cn https://www.robertwalters.cn/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true
Head of Regulatory and Quality Assurance - APAC of a multinational company which has reputable product of high value consumables.
Key Responsibilities:
- Manage the Regulatory Affairs departments ensuring resources and expertise are assigned to meet company goals, objectives and regulatory compliance. Provide ongoing coaching and feedback to develop the team for future Regulatory Affairs leadership in the region
- Ensure personal and team compliance, QMS procedures, policies and relevant medical device standards and regulations
- Provide expert opinions on technical and legal matters associated with the registration of products in the region to internal stakeholders
- Liaise and collaborate with various stakeholders in relation to all regulatory issues
- Facilitate communications between all stakeholders in order to get products registered in the region
- Liaise with all relevant distributors worldwide to ensure information flow and understanding of current processes
- Collaborate with regional leadership to support APAC focused business improvement activities
- Ensure timely and accurate reporting of key performance indicators in support of the regulatory metrics
- Maintain an excellent understanding of all medical device regulatory requirements
- Ensure all quality, regulatory, compliance, and product-specific requirements are met
Key Requirements:
- Bachelor Degree in life science related disciplines
- 10+ years of RA experience in Medical Device industry
- Experience with the regulatory environments of other Asian markets is preferred
- Allocates time and resources effectively and efficiently to achieve agreed outcome
- Well-organised, Ability to work under pressure
- Excellent verbal and written English and Chinese communications skills
What's on Offer:
- Competitive compensation
- Good company culture
- Opportunity to relocate to Singapore, Japan or other country of Asia
About the company:
Our client is a multinational company with which has reputable product of high value consumables.
