Staff Regulatory Affairs Specialist SSC
Company: Carl Zeiss Vision
Posted on: June 6, 2021
Staff Regulatory Affairs Specialist SSC
Step out of your comfort zone, excel and redefine the limits of
what is possible. That's just what our employees are doing every
single day - in order to set the pace through our innovations and
enable outstanding achievements. After all, behind every successful
company are many great fascinating people.
The Staff Regulatory Affairs Specialist is responsible for
preparing complex Class II and Class III 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 Staff Regulatory Affairs Specialist is also responsible
for the preparation of FDA annual reports for IDEs, PMAs, The Staff
Regulatory Affairs Specialist works closely with International
Regulatory Affairs to ensure that all products currently being sold
by Carl Zeiss Meditec have appropriate FDA clearance/approvals, are
properly device listed, and that regulatory submissions for new
products are done in a timely manner to facilitate product launches
in the United States.
We are looking for people who are keen to try something new:
- Works collaboratively with Global Regulatory Affairs 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
- Acts as point of contact with FDA and other regulatory
authorities such as IRBs and Ethics Committees for regulatory
- Prepares annual reports on IDEs, PMAs.
- Maintains the company's FDA regulatory files, including
regulatory submissions, FDA deficiency letters, company responses,
clearances/approvals, labeling, and all associated
- 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
- Reviews and approves marketing collateral for Regulatory
Affairs via the Marketing Communication Approval Form process.
- Partners with International Regulatory Affairs in Jena,
Oberkochen, and Munich 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
- Maintain and work to Company SOPs. Ensure that procedures are
adequate for conducting regulated clinical trials.
- Represents RA department on Project Teams, where
- Mentors junior regulatory staff and other team members, as
- Performs others duties, as assigned.
- Requires a Bachelors degree in an appropriate scientific
discipline. Advanced degree preferred.
- Eight years of experience in an FDA-regulated environment.
IDE/PMA experience preferred. 510(k) experience required.
- Must have excellent communication skills, both written and
oral, and must be computer literate.
- This position requires travel internationally to participate in
regulatory strategy planning with global product development teams
- Industry recognized certification (RAC) preferred.
In a spacious modern setting full of opportunities for further
development, ZEISS employees work in a place where expert knowledge
and team spirit reign supreme. All of this is supported by a
special ownership structure and the long-term goal of the Carl
Zeiss Foundation: to bring science and society into the future
Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your
application regardless of gender, nationality, ethnic and social
origin, religion, philosophy of life, disability, age, sexual
orientation or identity.
Apply now! It takes less than 10 minutes.
We are an EEO/AAA/Veterans/Disabled Employer
Keywords: Carl Zeiss Vision, Dublin , Staff Regulatory Affairs Specialist SSC, Other , Dublin, California
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