Regulatory Compliance Expert

5 days ago


Bedford, Bedford, United Kingdom Werfen Full time

Job Summary:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfen. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in China and Japan.

Key Responsibilities:

  • Participate in design and risk management teams to provide guidance on regulatory requirements for China NMPA and Japan PMDA.
  • Author and sign Regulatory Plans and Determinations for worldwide submissions.
  • Prepare new product registration packages for China NMPA and Japan PMDA.
  • Provide support materials for other country registrations.
  • Assist with product renewal packages to maintain country registrations.
  • Review and provide technical input on data and reports for regulatory submissions.
  • Maintain Regulatory Database in SAP.
  • Review and sign marketing and labeling materials.
  • Educate and train colleagues on international country registration and labeling requirements.

Requirements:

  • Bachelor's degree in engineering or science, advanced degree preferred.
  • Minimum 5 years' experience in medical device industry, in-vitro diagnostics a plus.
  • Experience in preparing technical submissions for NMPA and PMDA regulatory approval.
  • Demonstrated understanding of NMPA Decree and CFR 21/ISO requirements.
  • Excellent communication and analytical skills, with ability to prioritize and plan work in a fast-paced environment.

Preferred Qualifications:

  • RAC certification.
  • Language fluency in English and Chinese.
  • Cross-cultural project experience.


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