Senior RA Specialist in Beijing at Stryker Corporation

Date Posted: 6/29/2020

Job Snapshot

Job Description

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

Work From Home: Not available

Travel Percentage: 10%

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