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Staff Regulatory Affairs Specialist SSC

Company: Carl Zeiss Vision
Location: Dublin
Posted on: June 6, 2021

Job Description:

Staff Regulatory Affairs Specialist SSC

Dublin, CA

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 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.
  • 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 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 monitoring inspections.
  • Maintain and work to Company SOPs. Ensure that procedures are adequate for conducting regulated clinical trials.
  • Represents RA department on Project Teams, where appropriate.
  • Mentors junior regulatory staff and other team members, as requested.
  • Performs others duties, as assigned.

You are:

  • 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 together.

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

Online Application

Keywords: Carl Zeiss Vision, Dublin , Staff Regulatory Affairs Specialist SSC, Other , Dublin, California

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