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  • Job Title: Regional Regulatory Quality and Regulatory Affairs Specialist (New Position)
  • Location: Hong Kong

An exciting Regional Regulatory Quality and Regulatory Affairs Specialist position has been just created with a US Medical Device Company.

This is new regional team just set up in Hong Kong, the product is a number 1 brand worldwide with top market share.

You will Act as Medical Device Responsible Person / Quality contact for the company, as required by local laws and regulations:

 

  • Corresponding with regulatory agencies, attending to any regulatory visits / inspections and maintaining product device information in the regulatory systems
  • Ensure compliance with local regulatory and quality requirements, company’s Global Quality requirements and site quality system requirements.
  • Drive new product registration, manage variation and renewals, and facilitate communication between regulatory agencies & global & local functional teams


 

Quality

  • Support the reporting and quality obligations in the country including submission of medical device event reports.
  • Oversee quality processes such as product releases, product re-labelling, complaint investigations and reporting, change control, non-conformance, correct and preventive actions


Regulatory Affairs

  • Ensure ongoing compliance and maintenance of product registration to meet regulatory and business obligations
  • Manage variation submission and approval for any change in the products and manage the renewal of product registration

 

  • Degree holder in science
  • Basic knowledge in ISO9001, ISO 13485, GMP and GDP.
  • Knowledge of medical terms, local medical device laws and regulations,
  • Vigilance Reporting regulations
  • Expertise in the local GDP/GMPs for medical devices
  • Auditing Skills (advantage)
  • At least 3-5 years of experience in similar role or QARA experience in the pharmaceutical, medical device, aesthetics industry.
  • Experience in quality organization in a commercial business.
  • Exposure to ISO9001, GDP and GMP

***Regional / APAC Exposure***

500K - 600K per annual 

Interested parties please send your resume to monica.ling@talentbluesearch.com

Details

  • Reference #: TB-661
  • Industry: Pharmaceutical, Health Care and Medical
  • Job Function: Quality Assurance / Quality Control
  • Level: Officer
  • Annual Package: 1 Million below

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