Sr. Regulatory Affairs Specialist

Employer: Carl Zeiss Meditec, Inc.

Position: Senior Regulatory Affairs Specialist

Duties: Works collaboratively with Global Regulatory Affairs, Product Development Teams and Product Marketing to register products in the United States. Additionally, this person supports and as appropriate develops pre-launch regulatory strategies, and facilitates product launches in the United States. Prepare responses to FDA deficiency letters in support of regulatory clearance/approvals; Maintains the company's FDA regulatory files, including regulatory submissions, FDA deficiency letters, company responses, clearances and 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.

Education

Required: Master or foreign equivalent in Regulatory Affairs or related fields.

Pay Range:

The annual pay range for this position is $102,700 - $128,400.

The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.

This position is eligible for a Performance Bonus.

ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.

Your ZEISS Recruiting Team:

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).