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
Related jobs
-
Associate Director, Global Data Engineering USD 170K-224KAI Governance | AWS | Airflow | Apache Spark | AthenaMid-level Full TimeNutley, United States R6d ago
-
Associate Director Systems and Analytics USD 200K-276KCash Collections | Data Analysis | Data Visualization | Data reporting | ExcelHybrid work modelMid-level Full TimePalo Alto, CA, United States R9d ago
-
Associate Director, Clinical Outcomes Assessment - Quantitative Research - Digital Health R&D Oncology – Evinova USD 151K-226KAdverse Event | Adverse event analysis | Change Management | Clinical Outcomes | Clinical outcomes assessmentDental insurance | Health insurance | Paid time off | Retirement benefits | Vision insuranceMid-level Full TimeUS - Gaithersburg - MD, United … R16d ago
-
Associate Director – AI / Generative AI Engineering USD 98K-140KAI Evaluation | Cloud deployment | Data Governance | Generative AI | Language ModelsFlexible hybrid work model | Health and life insurance | Paid time off | Pension/retirement benefitsMid-level Full TimeJersey City, NJ, United States R1mo ago