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
- Communicate project timelines and address complex regulatory issues
- Develop regulatory affairs processes
- Develop regulatory strategy for new product clearances and approvals
- Evaluate device changes for regulatory submission requirements
- Generate submission ready regulatory documentation
- Lead regulatory strategy execution
- Prepare technical documents for global health authority submissions
- Prepare write and file FDA submissions
- Provide regulatory feedback on specifications device testing and risk management
- Support health authority communications
Perks/Benefits
- 401k savings plan
- Flexible schedule
- Holiday pay
- Hybrid work schedule
- Paid time off
- Parental leave
- Relocation assistance
- Sick leave
- Up to 25 percent travel
Skills/Tech-stack
Biocompatibility | Design Controls | Device Clearance | FDA Submissions | Global regulations | IEC 60601 | Letters to File | Medical Device | Medical Device Software Guidance | Medical device regulation | Medical device software | New Product Submissions | Regulatory Submissions | Regulatory documentation | Regulatory strategy | Reprocessing | Risk Management | Software guidance | Sterilization
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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