Senior Regulatory Affairs Specialist – Investigational Device Exemption – Ide
| Company | Intuitive Surgical |
|---|---|
| Location | Sunnyvale, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- B.S. or higher in Engineering or in a Science field (preferable)
- Minimum 5 years relevant experience working in a medical device company and/or applicable work for a regulatory agency
- 4 years of experience in submissions and technical documentation for medical devices
- Experience with new product development projects for complex products
- Experience in Investigational Device Exemption (IDE) submissions for clinical studies
- Ability to efficiently and effectively create FDA submissions, memo-to-files, and technical documentation for complex new products
- Good understanding of design controls with experience in verification and validation methods and documentation
- Able to work effectively and adapt in a dynamic, early start up-like environment
- Understanding of third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization
- Verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
- Interpersonal skills and able to work well with cross-functional teams
- Proven project management skills
Responsibilities
- Prepare and submit 510(k)s and IDEs for new products, new indications, and significant product changes in a timely manner
- Support clinical study strategy and design as it relates to supporting Regulatory filings
- Prepare ‘Memo to File’ documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals
- Support product development teams on regulatory issues, including review of documentation
- Provide leadership on documentation issues and mentor teams on regulatory requirements
- Support continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process
- Work directly with regulatory agencies on regulatory issues and submissions
- Support international regulatory efforts as needed
- Perform other duties as required
Preferred Qualifications
-
No preferred qualifications provided.