Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery
US052 OH Cincinnati - 4545 Creek Rd, United States
R
USD 109K-201K Senior-level Full Time
Tasks
- Author regulatory submissions
- Conduct regulatory evaluation of device changes
- Develop regulatory affairs processes
- Develop regulatory strategy for medical devices
- Execute regulatory strategy for robotic instruments and accessories
- Generate regulatory submissions including Letters To File
- Prepare and author global health authority technical documentation
- Prepare write and file FDA submissions
- Provide regulatory feedback on specifications device testing risk management
- Support health authority communications
Perks/Benefits
- N/A
Skills/Tech-stack
510(k) | Biocompatibility | De Novo | Device Risk | Device Risk Management | FDA Submissions | Global Regulatory Requirements | IDE | IEC 60601 | Letters to File | Medical Device | Medical device regulations | Q-Submission | Regulatory Compliance | Regulatory Submissions | Regulatory requirements | Regulatory strategy | Regulatory subject matter expertise | Reprocessing | Risk Management | Sterilization | Subject Matter Expertise | Technical documentation
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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