Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery
USD 157K-271K Mid-level Full Time
Tasks
- Apply guidance regulations standards
- Define and execute regulatory strategies for software subsystem vision systems endoscopes integrated robotic system
- Lead and develop regulatory team members
- Manage internal resources and contractor SMEs
- Manage premarket regulatory submissions to US FDA
- Manage software and vision regulatory team
- Manage sustaining activities and change assessments
- Obtain market access for new product introduction
- Serve as regulatory leader for software and vision subsystems
- Serve as regulatory subject matter expert
- Support audits
Perks/Benefits
- N/A
Skills/Tech-stack
510(k) | Change Assessment | Cybersecurity Requirements | EU MDR | FDA Software and Cybersecurity Requirements | IDE | Letter To File | Lifecycle Management | Market Access | Medical Device | Medical Device Regulatory | Medical Device Regulatory Compliance | People management | Premarket Submissions | Program Management | Q-Subs | Regulatory Affairs | Regulatory Compliance | Regulatory strategy | US market access
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
Regions
Countries
States
Cities
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