Regulatory Affairs Specialist (12 months contract)

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  • Hong Kong, Hong Kong
  • Taipei City, Taiwan
Job details
Work flexiblity: Hybrid Req ID: R520595 Employee type:
  • Full Time
  • Temporary
Job category: RAQA Travel: 0% Relocation: No

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Job description

As the healthcare landscape evolves, we are hiring a Regulatory Affairs Specialist on a 12-months contract to ensure that Stryker proactively registers relevant products to comply with regulations. You will be guided by industry professionals and your work will have a direct impact on making healthcare better! 

Subject to the business needs and performance of the incumbent, 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.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Apply Now