Senior Regulatory Affairs Specialist
3 weeks ago
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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