Junior Regulatory Affairs Manager

6 days ago

Beijing, Beijing, China Bayer Full time

At Bayer, we are innovators committed to addressing the world's most pressing challenges, striving for a reality where 'Health for all, Hunger for none' is achievable. Our journey is fueled by energy, curiosity, and unwavering dedication, as we learn from diverse perspectives, broaden our understanding, enhance our skills, and redefine what is possible.

Position: Associate RA Manager

KEY RESPONSIBILITIES

  • Develop and implement registration strategies for new products, ensuring a comprehensive project plan is in place. Lead the registration process in alignment with established strategies and timelines.
  • Oversee regulatory activities for the ongoing maintenance of marketed products.
  • Monitor project progress closely, maintaining adherence to timelines. Prepare submission dossiers for health authorities and provide timely feedback to testing laboratories and stakeholders.
  • Participate in additional responsibilities such as contributing to SOP/OI Taskforces, regulatory intelligence, and competitor analysis.
  • Review and approve labeling in compliance with local regulations.
  • Ensure compliance with internal policies, systems, databases, and local regulatory requirements for all responsible projects.
  • Communicate project status updates regarding pre-market submissions to key stakeholders and management.
  • Facilitate type testing activities, promptly addressing and resolving any issues with the engineering team to mitigate post-market compliance risks.
  • Conduct assessments and gap analyses for new standards and regulations.
  • Evaluate regulatory implications of design changes to ensure compliance.
  • Perform other duties as assigned by management.

QUALIFICATIONS

  • Advanced technical degree in Electrical Engineering, Biomedical Engineering, or a Bachelor’s degree with a minimum of 5 years of regulatory experience.
  • In-depth knowledge of NMPA regulations governing medical device administration.
  • Familiarity with medical device development processes and product maintenance requirements.
  • Exceptional written and verbal communication skills, with proficiency in English.
  • Proven ability in planning, organization, customer focus, and teamwork.

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