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Senior Regulatory Affairs Specialist
2 months 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.
- Educate and train IL personnel on international country registration and labeling requirements.
Requirements:
- Bachelor's degree in engineering or science, advanced degree.
- 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.
- Demonstrated understanding of NMPA Decree and CFR 21/ISO requirements.
Preferred Qualifications:
- RAC certification.
- Language fluency: English and Chinese essential.
About Werfen:
Werfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments and related products. We operate in over 30 countries and have a strong commitment to innovation, quality, and customer satisfaction.
