- Identifies, analyzes and implements U.S. country specific requirements necessary for product related medical device FDA submissions
- Plans and prepares product related premarket medical device submissions with Siemens internal or external organizations according to regulatory requirements
- Performs regulatory projects or acts as a member of the project steering group
- Submits required documentation/information to U.S. authorities (FDA) or Siemens internal organizations
- Acts as Siemens’ interface in all interactions with FDA (e.g., meetings, teleconferences, and in writing)
- Escalates necessary activities if deviations are identified
- Performs review of promotional material and products being introduced into the U.S. market for regulatory compliance according to country specific (U.S.) requirements
- Ensures creation of adequate documentation for audits/inspections
- May represent the company in industry associations (e.g. – MITA, AdvaMed, etc.)
- May create quality guidelines and work instructions relevant for maintaining regulatory compliance
- Develops processes and systems to deliver functional objectives
- Plans own work according to agreed targets by integrating resources in a project driven environment
- Provide functional advice and guidance to colleagues and internal/external customers
- 3 - 5 years of experience in medical device regulatory affairs (experience with 510(k), PMA, QSR, etc.). Imaging experience is a plus.
- Successful demonstration of Key Responsibilities, Knowledge, Influence & Impact as presented above
- Possesses a chartered professional qualification (e.g., RAC, etc.) or equivalent.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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