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Regional RA Specialist (12 months Contractor, remote)

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As the healthcare landscape evolves, we are hiring a Regulatory Affairs Specialist on an initial 12-months contract to ensure that proactively registers relevant products to comply with regulations. There is possibility for this contract role to be extended or converted to a permanent position. This role can either be based in Hong Kong or Taiwan.

Key Responsibilities:

  • Identify, collect and maintain files / information on local and regional regulatory intelligence in relevant databases / systems.
  • Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.)
  • Provide information used to evaluate proposed products for regulatory classification and jurisdiction.
  • Research requirements, applicable guidelines and options for regulatory submissions, approval pathways, and compliance activities.
  • Organize materials from preclinical and clinical studies for review and assist in the review process.
  • Compile and organize materials for pre-submission reports and communications.
  • Assist in the preparation of dossiers and submission packages for regulatory agencies.
  • Track the status of applications under regulatory review and provide updates to the regulatory team.
  • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
  • Assist in post market surveillance activities - e.g. logging and reporting of customer complaints and follow-up activities

Requirements:

  • Bachelors Degree in Engineering, Science, or other related fields.
  • 1 - 2 years of relevant experience in RA / QA in the medical device industry.
  • Demonstrated ability to learn and apply new knowledge quickly.
  • Strong command of written and spoken English and Mandarin (to manage the stakeholders in Taiwan and Hong Kong)
  • Excellent time management and coordination skills.
  • Strong communication skills - ability to clearly convey information internal and external stakeholders.
  • Resourceful to seek out diverse ideas, information and insights, and apply them to the work at hand.

Contract Type: FULL_TIME

Specialism: Healthcare

Focus: RA & QA

Industry: Pharmaceuticals

Salary: Negotiable

Workplace Type: Hybrid

Experience Level: Entry Level

Location: Taipei

Job Reference: LRL4N3-4833E490

Date posted: 24 June 2024

Consultant: Rica Chuang

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