Location: Santa Clara, California, United States
Job Summary:
Job Duties and Scopes:
- Create and maintain Clinical Evaluation Plans, Reports, and Summary of Safety and Clinical Performance.
- Identify and analyze clinical evidence for regulatory submissions.
- Review documentation for alignment with risk information.
- Manage timelines and communicate project risks with cross-functional teams.
- Provide strategic guidance on regulatory requirements and support audits.
Required Skills:
- Expertise in writing, editing, and managing technical documentation.
- Proficiency in project management, communication, and analytical skills.
- Ability to handle multiple projects and meet deadlines.
- Strong interpersonal and presentation skills.
Required Experiences:
- Bachelor’s Degree in Science or relevant discipline.
- Minimum 3 years of experience in R&D, Technical Product Development, or Quality in healthcare.
- Experience in writing CERs and related documents per regulations.
- Familiarity with medical device regulations and quality systems.
Job URLs: