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Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

As the healthcare landscape evolves in Hong Kong, we are hiring a Regulatory Affairs Specialist on an initial 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.

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 Cantonese (to manage local authority stakeholders). Spoken and written Mandarin is an added advantage.

• 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.

About Stryker

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 130 million patients annually. More information is available at stryker.com. (http:)

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.