Regulatory Compliance Associate Manager

2 months 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 horizons, enhance our skills, and redefine what is possible. There are countless reasons to be part of our team. If you are eager to cultivate a diverse and impactful career within a community of exceptional and varied talents, your path begins here.

Position: Associate RA Manager

KEY RESPONSIBILITIES

  • Develop and implement registration strategies for new products, creating comprehensive project plans.
  • Oversee regulatory processes for the maintenance of existing products in the market.
  • Monitor project timelines closely, ensuring timely preparation of submission dossiers for health authorities and maintaining effective communication with testing laboratories and stakeholders.
  • Participate in additional responsibilities such as contributing to SOP/OI Taskforces, regulatory intelligence, and competitor analysis.
  • Review and validate labeling in compliance with local regulations.
  • Ensure adherence to internal policies, systems, databases, and local regulatory compliance for all assigned projects.
  • Communicate project status updates regarding pre-market submissions to key stakeholders and management.
  • Facilitate type testing activities, addressing and resolving issues with engineering teams promptly to mitigate post-market compliance risks.
  • Conduct assessments and gap analyses for new standards and regulations.
  • Evaluate regulatory implications of design modifications 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 abilities in planning, organization, customer focus, and teamwork.


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