Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery
USD 109K-201K Senior-level Full Time
Tasks
- Author regulatory submissions
- Develop regulatory affairs processes
- Develop regulatory strategy
- Evaluate device changes
- Generate regulatory submissions
- Guide conformance with regulations and guidance
- Lead regulatory submissions
- Prepare FDA submissions
- Prepare global regulatory technical documents
- Provide regulatory feedback for risk management
- Review product specifications and testing documentation
- Support health authority communications
Perks/Benefits
Skills/Tech-stack
510(k) | Biocompatibility | Change evaluation | De Novo | Design Control | Device Reprocessing | FDA Submissions | Health Authority | Health Authority Meetings | IDE | IEC 60601 | Labeling | Medical Device | Medical Device Software Guidance | Medical device regulation | Medical device software | Process Development | Q-Submission | Regulatory Affairs | Regulatory Affairs Process Development | Regulatory Change Evaluation | Regulatory Submissions | Regulatory change | Regulatory guidance | Regulatory strategy | Risk Management | Software guidance | Sterilization | Technical documentation
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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