Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery
US052 OH Cincinnati - 4545 Creek Rd, United States
R
USD 109K-174K Senior-level Full Time
Tasks
- Author regulatory submissions
- Conduct regulatory evaluations of device changes
- Develop regulatory strategies
- Execute regulatory strategy
- Manage regulatory submissions for medical devices
- Prepare and file FDA submissions
- Prepare regulatory submission documentation
- Provide regulatory feedback to engineering teams
- Review risk management documentation
- Review specifications and device testing documentation
- Support health authority communications
- Support regulatory process development
Perks/Benefits
Skills/Tech-stack
510(k) | Biocompatibility | De Novo | Design Controls | Device Design | Device Design Controls | Device Reprocessing | FDA Submissions | Global regulations | IDE | IEC 60601 | Labeling | Medical Device | Medical Device Regulatory | Medical device regulatory submissions | Promotional Materials | Q-Submission | Regulatory Submissions | Regulatory documentation | Regulatory strategy | Risk Management | Sterilization validation | Technical documentation | Technical writing
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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