Senior Regulatory Affairs Specialist (Beijing)

2-4 years
5 days ago
Job Description

Are you interested in working for a global company where you can work across functions and on awide-varietyof 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

Position summary:

Develop and execute plans to get products registered for sales in China and to ensure product distribution and

sales in China are in compliant with Chinese laws and regulations, as well as Stryker company's rules and

requirements

Essential Duties & Responsibilities: (Detailed Description)

. Prioritize, plan, and review product registrations for respective product lines

. Prepare, coordinate and submit regulatory applications to the local health authority

. Maintain an active knowledge of the status of pending approvals and shepherd registrations through

the approval process.

. Provide the management team with regular updates on product registration.

. Establish and implement plans to maintain a trusted relationship with the local health authorities

through regular meetings, discussions, training and education

. Lobby with local health authorities using constructive/scientific challenges to regulations. This should

include guidance on alternative solutions to country regulatory needs

. Support tender operations by timely supply of accurate regulatory documents

. Establish relationships with local medical device industry groups and work with industry peers to

lobby the Competent Authorities in matters of regulatory issues and to influence local policies.

. Establish and maintain a good working relationship with regional RA peers to gain positive & timely

support for document preparation.

. Serve as regulatory consultant to marketing team and government regulatory agencies

Education & Experience:

. Bachelor degree in Medicine or Bioengineering or above preferred.

. Relevant regulatory and quality assurance experiences in international company for more than 2 years

Physical & Mental Requirements:

. Well-organized and logical thinking

. Good at planning and business processes,

. Detailed oriented

. Professional communication skills

. Patience and a great sense of responsibility

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

JOB TYPE

Function

Skills

Regulatory Consultant
Regulatory Applications
Medical Device Industry
About
Job Source: careers.stryker.com

Stryker is one of the world&#8217&#x3B;s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at stryker.com and careers.stryker.com.

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