Location: Santa Clara, CA
Job Summary:
1. Job Duties and Scopes:
- Drive a vibrant regulatory culture and collaborate with cross-functional teams.
- Develop and implement regulatory strategies for new product clearances and approvals.
- Prepare and submit regulatory documentation for FDA and global health authorities.
- Serve as a subject matter expert on regulatory affairs in product development.
- Conduct regulatory evaluations and guide compliance with applicable regulations.
2. Required Skills:
- Strategic regulatory thinking and technical expertise.
- Strong knowledge of FDA submission processes and global regulatory requirements.
- Excellent communication and problem-solving abilities.
3. Required Experiences:
- Experience in regulatory affairs, particularly with new product development.
- Proven track record in preparing regulatory submissions (e.g., 510(k), IDE).
- Familiarity with risk management and device testing documentation.
Job URLs: