The Senior Staff Regulatory Affairs Specialist US is responsible for preparing FDA regulatory submissions in support of product clearances and approvals. This includes responsibility for preparing pre-market notifications, premarket approval (PMA) applications and investigational device exemptions (IDEs). The Senior Staff Regulatory Affairs Specialist US is also responsible for the preparation of FDA annual reports for IDEs, PMAs, and radiation and laser reports. This position works closely with International Regulatory Affairs to ensure that all products currently being sold by Carl Zeiss Meditec have appropriate FDA clearance/approvals, that the device is properly listed, and that regulatory submissions for new products are completed to facilitate product launches in the United States.
Works collaboratively with International Regulatory Affairs (e.g. in Jena, Oberkochen, Munich, Shanghai, Bangalore) and Product Marketing to develop pre-launch regulatory strategies, and supports product launches in the United States with timely submission of premarket notifications and PMAs.
Prepares premarket notifications, PMAs, IDEs for submission to FDA.
Prepare responses to FDA deficiency letters in support of regulatory clearance/approvals.
Acts as point of contact with FDA and other regulatory authorities such as IRBs and Ethics Committees for regulatory issues.
Prepares annual reports on IDEs, PMAs, and radiation and laser products for submission to FDA.
Maintains the company’s FDA regulatory files, including regulatory submissions, FDA deficiency letters, company responses, clearances/approvals, labeling, and all associated correspondence.
Works collaboratively with Clinical Affairs to submit clinical studies to Institutional Review Boards (IRBs) and/or Ethics Committees for approval and oversight. Submits annual reports and study closure reports to IRBs on an annual basis or as required based on study activity.
Reviews product labeling to ensure compliance with regulatory clearances/approvals.
Reviews and approves marketing collateral for Regulatory Affairs via the Marketing Communication Approval Form process.
Partners with International Regulatory Affairs (e.g. in Jena, Oberkochen, Munich Shanghai, Bangalore) to ensure US regulatory compliance. This includes internal or external audits, as necessary to ensure compliance with FDA regulations, including Good Clinical Practices. Provides support for FDA inspections, including bioresearch monitoring inspections.
Maintain and work to Company SOPs. Ensure that procedures are adequate for conducting regulated clinical trials.
Supports Product Complaint investigations, as required.
Mentors and supports the work of Sr. and Staff level Regulatory team member s