Senior Regulatory Affairs Specialist

3 weeks ago


Bedford, Bedford, United Kingdom Werfen Full time

Job Summary:

Werfen is seeking a highly skilled Senior 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 promotional materials, labeling, and change orders.
  • Develop and maintain relationships with domestic and international teams.

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.
  • Strong understanding of NMPA Decree and CFR 21/ISO requirements.

What We Offer:

Werfen is a global leader in medical devices, with a strong commitment to innovation and quality. We offer a dynamic and challenging work environment, with opportunities for professional growth and development.



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