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RA/QA Supervisor(TW/HK)

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Our client is seeking a highly skilled and experienced RA/QA Supervisor to oversee their operations in Taiwan, Hong Kong, and Macau. This role is pivotal in ensuring that all products meet the necessary regulatory requirements. The successful candidate will be responsible for class I, II, III, IV and QSD registration and will play a key role in developing registration strategies.

What you'll do:

As an RA/QA Supervisor, your role will be multifaceted. You will be tasked with compiling and submitting new product registrations, monitoring changes to regulations, providing regulatory support, developing regulatory strategies, aligning registration plans with marketing strategies, conducting post-market surveillance, maintaining relationships with TFDA, updating new regulations/requirements. Your ability to navigate these responsibilities effectively will be crucial for the continued success of the business.

  • Compile and submit new product registrations, license extensions, changes, and renewal according to the submission plan
  • Monitor changes to regulations and policies and proactively identify issues that may impact the business
  • Provide regulatory support to compliance and tender in Hong Kong and Macau
  • Develop regulatory strategy in response to updates or changes in regulations
  • Align registration plan with marketing strategy to support business growth
  • Conduct post-market surveillance including reporting defective quality warning and product recall in Taiwan
  • Maintain relationships with TFDA and update new regulations/requirements to company and Global RA

What you bring:

The ideal candidate for this RA/QA Supervisor role brings a wealth of experience in regulatory affairs for medical devices. With a minimum of 6 years' experience under your belt, you are well-versed in navigating the complexities of this field. Your excellent communication skills enable you to liaise effectively with various departments while your strong problem-solving abilities allow you to anticipate potential risks. Your ability to work independently is crucial as you will be overseeing operations across multiple regions.

  • Bachelor’s degree in engineering, Science, or related field
  • Minimum 6 years’ experience in regulatory affairs for medical devices
  • Excellent communication skills with proficiency in spoken and written English and Chinese
  • Ability to monitor changes to regulations and policies
  • Strong problem-solving and analytical skills
  • Ability to work independently

What sets this company apart:

Our client is a leading player in the medical device industry. They pride themselves on their commitment to continuous learning and broadening business value. Their focus on building customer loyalty through high-quality products sets them apart from competitors. They offer a supportive environment where planning, organising, and a great sense of responsibility are highly valued.

What's next:

Ready to take the next step in your career? Don't miss this exciting opportunity!

Apply today by clicking on the link. We look forward to receiving your application!

Contract Type: FULL_TIME

Specialism: Healthcare

Focus: RA & QA

Industry: Pharmaceuticals

Salary: Negotiable

Workplace Type: Hybrid

Experience Level: Associate

Location: Taipei

Job Reference: OIIBYY-F9CFE969

Date posted: 01 October 2024

Consultant: Rica Chuang

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