RA&QA Manager, Medical Device MNC, up to HK$900k annual package
Leading medical device MNC listed on NYSE
Attractive 13 months guarantee salary plus bonus
About Our Client
Our Client is a leading company in medical device listed in NYSE. Their goal is to growth high quality vegetables for local and regional customer. Due to the rapid expansion and market demand, they are looking for a RA&QA Manager to join their organization. The position will be report to Asia Hub directly.
Our client is currently recruiting a RAQA manager responsible for leading a team of regulatory/quality professionals through setting goals and objectives that are aligned with the region/country business strategy.
The duties include:
- Deals with the regulatory issues and submissions and/or provides a framework for negotiations with Government officials on these issues.
- Act as interface between Hong Kong RAQA management and Regional / Country Management.
- Ensures implementation of national requirements and technical regulations including local legislation on environmental regulations with respect to product handling distribution, supply & waste handling.
- Coordinates the timely execution and management of post-market surveillance activities such product complaint handling and regulatory authority inquiries.
- Develops and maintains an effective working relationship with the authorities.
- Ensures that regulatory requirements regarding clinical trials are implemented by MDCO/ MDD and local clinical organizations.
- Issue and review with management (local and functional) an annual organizational development plan that focuses on risks and critical needs.
- Ensures the ISO-13485 quality system will be successfully re-certified and extended where applicable. This function is formally represented as the Management Representative for the quality systems.
- Promote compliance with corporate policies by means of implementing the procedures defined in the QA system
- Represent and coordinate active participation in the development and shaping of technical regulations, technical standards and related policies to Company's business & therapies
The Successful Applicant
The successful candidate will have experience in RA and QA towards medical device:
- BSc. or BA in Medical/Clinical field, Science or BSc. Engineering
- 5-7 years of experience in the regulatory function, preparing submissions and negotiations experience with regulatory authorities and Quality experience
- Political and Government Regulatory Systems
- Government Submission Requirements
- Key Regulatory decision makers in the government
- In depth industry knowledge to QA system demographics and regulations
What's on Offer
Your commitment and passion to drive the operation will be rewarded with a highly lucrative remuneration package including attractive 13 month's guarantee salary plus performance bonus. Operating within a dynamic and friendly environment, substantial resources will be provided in support of the delivery of your duties.