Regulatory Specialist II
4 weeks ago
Role: Regulatory Specialist II
Location: Alameda, CA- 94502
Duration: 12 Months
Skills Looking For
Ongoing regulatory submissions and document management for medical devices in APAC countries.
Handling changes and assessments based on country-specific regulations.
5+ years of experience in medical device regulatory submissions.
APAC submission writing experience, especially in high-regulation countries (China, Japan, Korea, and Australia).
Ability to manage multiple regulatory submissions and projects.
Strong understanding of regulatory requirements and standards.
Medical device industry experience is a must.
Preparing regulatory submissions for APAC countries.
Experience handling Class C or Class 3 medical devices.
Strong problem-solving skills in regulatory contexts.
Submission experience with strict regulatory bodies (e.g., Japan, Korea, China).
Strong knowledge of regulatory standards like ISO 13485.
Communicating with internal teams and regulatory agencies to ensure compliance.
Managing multiple projects simultaneously.
Education and Level of Experience:
Bachelor's degree in engineering or science preferred.
Minimum of 5 years of regulatory experience in the medical device industry (Writing submissions from beginning to end for APAC countries)
Internship, Projects, or Co-op experience will not be considered.
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