Senior RA Specialist in Beijing at Stryker Corporation

Date Posted: 9/7/2018

Job Snapshot

Job 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

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  • Bachelor degree in Medicine or Bioengineering or above preferred.

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

"

Work From Home: No

Travel Percentage: None

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