Sr. RA Manager, LS China Platform

Danaher

  • Beijing
  • Permanent
  • Full-time
  • 17 days ago
OverviewAs a Life Sciences China Senior RA Manager, your primary responsibilities are to manage regulatory matters in Life Science China (LSC) platform, develop and implement regulatory strategies to ensure the LS RA operation and op-cos compiles with applicable regulations and local laws. This position will require you to be knowledgeable in clinical trial, regulatory and NMPA requirements on MD/IVD, familiar with medical device registration process in China, and excellent in team management. Collaboration with different op-co management teams, internal and external partners is crucial to fulfilling the responsibilities of this role.Roles & ResponsibilitiesAs an Automation Systems Engineer, you will:
  • Develop and improve regulatory operation system and process for LSC platform and monitor the execution of the RA team.
  • Build and develop high performing regulatory affairs team on LS platform. Lead and mentor the RA team, ensure team competence to match the job.
  • Plan for registration projects with budget management, to achieve NMPA certificates in reasonable timeline efficiently.
  • Work collaboratively with cross-functional teams including manufacturers, R&D, sales, global RA, project teams, as well as China Management team. Ensure import products comply with China regulations and standards.
  • Provide regulatory input to strategic decision making and prioritization. Provide regulatory and registration supports to China localization project under LS platform.
  • Lead regulatory intelligence activities, provide regulatory guidance and support throughout the product lifecycle.
  • Act as external contacts for this position include NMPA, testing labs, standard committee, associations.
  • Analyze data from clinical trials to determine the efficacy and safety of products.
  • Perform other work assigned by supervisor.
Qualifications and Skills
  • Bachelor’s degree in clinical medical, pharma, biomedical, or engineering majors
  • Proficiency in English as working language.
  • Excellent critical thinking skills and the ability to solve complex issues.
  • Effective communication and collaboration skills to work with cross-functional teams.
  • Ability to work in a challenging environment and manage multiple projects simultaneously.
  • Due to the time difference between EU, USA and China, some T-cons may be held late at nights.
ExperiencesThe ideal candidate should possess:
  • More than 5 years of RA manager experience
  • Working experience in medical device/IVD regulated industry.
  • Lead a team in the past.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.For more information, visit .

Danaher