Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery
US328 CA Santa Clara - 5490 Great America Pkwy, United States
R
USD 157K-271K Mid-level Full Time
Tasks
- Apply guidance regulations and standards to product portfolio
- Define regulatory strategies for software subsystem and vision systems
- Enable lifecycle management activities
- Lead and develop regulatory team members
- Lead regulatory submissions for US FDA 510k IDE Qsubs
- Manage internal resources and contractor SMEs
- Manage premarket regulatory submissions
- Manage sustaining change assessments registrations and renewals
- 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
Skills/Tech-stack
510(k) | Change Assessment | Cybersecurity | Device Compliance | EU MDR | FDA Regulations | IDE | IEC 60601 | ISO 10993 | Letter To File | Medical Device | Medical Device Compliance | Medical device regulations | Premarket Submissions | Qsub | Regulatory Affairs | Regulatory Compliance | Regulatory strategy | Software lifecycle | US EU Global Regulatory
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Regions
Countries
States
Cities
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