Senior 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.

Experience

Required: 1 year of experience in the job offered or related occupations (e.g., Medical Writer).

Special

Requirements: Must have at least 1 year of prior work experience in the following:

Have worked in the FDA-regulated 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 Consolidating clinical brochures of diagnostic assays to fit regulatory and quality standards per FDA guidance documents Performing reviews per FDA standards and formulating submissions including PMA supplements, 30-day Notices, Annual Reports and Annual Report Amendment Authoring Technical Files to achieve CE-mark and International Product Master File chapters for successful product registrations across non-EU countries

Worksite: 5300 Central Parkway, Dublin, CA 94568

Salary: $80,000 - $124,000 per year

Your ZEISS Recruiting Team:

Jo Anne Mittelman

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).