Senior Regulatory Affairs Specialist

4 weeks ago


Bedford, Bedford, United Kingdom Werfen Full time

Job Summary:

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Werfen. As a key member of our Regulatory Affairs department, 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 China NMPA and Japan PMDA requirements.
  • 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 the medical device industry, in-vitro diagnostics a plus.
  • Experience in preparing technical submissions for NMPA and PMDA regulatory approval.
  • Strong analytical and strategic thinking skills, excellent communication and project management skills.
  • RAC certification and language fluency in English and Chinese are highly desirable.

What We Offer:

Werfen is a global leader in the medical device industry, with a strong commitment to innovation and quality. We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, we encourage you to apply.



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