Senior Specialist in Regulatory Compliance

4 weeks ago


Bedford, Bedford, United Kingdom Werfen Full time

Position Overview:

The role involves overseeing the registration and renewal processes for IL-labeled products with the China NMPA and Japan PMDA. This position requires collaboration with design and risk management teams, the development of regulatory strategies for new and modified products, the upkeep of Technical Files, and the assurance of regulatory adherence.

Primary Responsibilities:

  • Act as the regulatory liaison on design and risk management teams
  • Compile and submit registration documentation for China NMPA and Japan PMDA
  • Evaluate and authorize marketing materials and product labeling
  • Provide training to IL staff on international registration protocols
  • Undertake additional RA/QA responsibilities as required

Required Skills & Qualifications:

  • Proficient decision-maker with strong communication abilities
  • In-depth understanding of NMPA and PMDA regulations
  • Minimum of 5 years' experience in the medical device sector
  • Robust project management capabilities; RAC certification is advantageous
  • Fluency in English and Chinese is essential

Company Profile:

Werfen stands as a prominent figure in the realm of specialized diagnostic instruments and solutions, catering to healthcare professionals globally. With a presence in over 30 nations, our commitment lies in innovation, quality, and enhancing patient care.



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