Sr Regulatory Affairs Specialist
Sr Regulatory Affairs Specialist
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Job Description
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 prelaunch regulatory strategies and facilitates product launches in the United States. Prepare responses to FDA deficiency letters in support of regulatory clearance/approvals; Maintains the companys 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.
Experience
Required: 3 years of experience in the job offered or related occupations (e.g. Medical Writer).
Special
Requirements: Must have at least 3 years of prior work experience as follows:
Work in an FDAregulated environment Consolidating responses for FDA Not Approvable Letters Designing and drafting the labels used at clinical testing sites (Verification & Validation labels) to comply with regulatory requirements including 21 CFR ISO 13485 ISO 14791 and EU Medical Device Directive 93/42/EEC Performing reviews per FDA standards and formulating submissions including PMA supplements 30day Notices Annual Reports and Annual Report Amendment Authoring Technical Files to achieve CEmark and International Product Master File chapters for successful product registrations across nonEU countries
Worksite: 5300 Central Parkway Dublin CA 94568
Salary: $128000 $130000 per year
Your ZEISS Recruiting Team:
Jo Anne MittelmanZeiss 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).
Required Experience:
Senior IC
Employment Type
Full-Time
