Senior RA Specialist - 27777BR - EI in Beijing at Stryker Corporation

Date Posted: 2/23/2018

Job Snapshot

  • Employee Type:
  • Location:
  • Job Type:
    Regulatory Affairs
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

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

Job Requirements

  • Bachelor degree in Medicine or Bioengineering or above preferred.
  • Relevant regulatory and quality assurance experiences in international company for more than 2 years