Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery
USD 157K-271K Mid-level Full Time
Tasks
- Apply expert knowledge of guidance regulations and standards
- Define and execute regulatory strategies for software subsystem vision systems and integrated robotic systems
- Lead and develop regulatory team members
- Manage premarket regulatory submissions to US FDA
- Manage sustaining activities change assessments and registrations
- Obtain market access for new product introductions
- Serve as regulatory leader for software and vision subsystems
- Serve as regulatory subject matter expert for software lifecycle cybersecurity and connected systems
- Support audits
Perks/Benefits
- 401k matching
- Caregiver leave
- Hybrid work schedule
- Paid time off
- Parental leave
- Relocation assistance
- Volunteer leave
Skills/Tech-stack
Change Assessment | Cybersecurity compliance | Device Lifecycle Management | EU MDR | FDA 510k | FDA Regulations | Global regulatory compliance | IDE | Letter To File | Lifecycle Management | Medical Device | Medical device lifecycle | Medical device lifecycle management | Medical device regulations | People management | Premarket Submissions | Program Management | Regulatory Affairs | Regulatory Compliance | Regulatory Submissions | Regulatory strategy | Software Lifecycle Management | Software lifecycle | US FDA | US FDA Regulations
Education
Regions
Countries
States
Cities
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