Regulatory Affairs Specialist

4 weeks ago


Bedford, Bedford, United Kingdom Werfen Full time

Job Summary:

Werfen is seeking a highly skilled Regulatory Affairs Specialist to join our team. 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 sign labeling and Change Orders.
  • Develop and maintain Regulatory Database in SAP.

Requirements:

  • Bachelor's degree in engineering or science, advanced degree.
  • Minimum 5 years' experience in the medical device industry.
  • Experience in preparing technical submissions for NMPA and PMDA regulatory approval.
  • Knowledge of NMPA Decree and CFR 21/ISO requirements.

Preferred Qualifications:

  • RAC certification.
  • Language fluency in English and Chinese.

About Werfen:

Werfen is a global leader in the development, manufacturing, and distribution of medical devices. We operate in over 30 countries and have a strong commitment to innovation and quality.



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