Cinderella Media Group Recruit.com.hk
This job is already expired. Here to continue job search.
Employer Ref: 4105774/001_157467202760094
Recruit Ref: L0457253605
Posting Date: 2019-11-25
Michael Page
Michael Page

As part of PageGroup, Michael Page is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world's top employers. PageGroup operates through 155 offices in 35 countries worldwide. First established in London in 1976, we've been bringing jobseekers and employers together for more than 30 years. London listed, we opened our first Asian office in Hong Kong in 1994 and currently we have offices in all major business hubs across the APAC region, including Australia, Singapore, Tokyo, Malaysia, India, Taiwan, Shanghai, Beijing, Shenzhen, Guangzhou, Pudong and Suzhou.

So if you're looking to take your career to the next level, visit www.michaelpage.com.hk

RA&QA Manager, Medical Device MNC, up to HK$900k annual package

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.

Client Details

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.

Description

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

Profile

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

Knowledge within,

  • 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

Job 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.

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Jeff Poon on +852 3412 4841



*** Click here to apply. ***

Summary
Industry:
Employment Agency 
Job Category / Function:
Job Position Level:
Senior 
Employment Term:
Full Time / Permanent 
Min. Edu. Level Req:
Bachelor 
Total Working Exp:
-- 
Salary(HKD):
--
Location:
Central & Western District / Central
Benefits:
  • Birthday Gift
  • Flexible Working Hours
  • Free Shuttle Bus
  • Housing Allowance
  • Labour / Statutory Holiday
This job is already expired. Here to continue job search.

Keywords: QA,RA,ISO,ISO 13485,MDCO
Maximum 5 Temporary Records Limit Reached!
Please Login or Register!
Recruit will store the information provided relating to your preference for jobs and your personal details in our proprietary database. This information is held in the strictest confidence and will not be disclosed to any third party without your prior approval. We may use the personal data we collect to notify you about our new services and special offers. However, if you request to delete your personal information from our database, please contact us at service@recruit.com.hk.