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Quality and Regulatory Affairs Specialist 2 Job ID 78856 Location: USCACarlsbad Experience Level: 35 years Education Level: Bachelors degree Type of Function: ...
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For your reference, we have included the original job posting below.
Regulatory Affairs Leader
Job Number:
25933603
Company Name:
Life Technologies
Job Location:
Carlsbad, CA US
Job Category:
Healthcare & Medical
Regulatory Affairs Leader
Auto req ID 5025BR Position Title Regulatory Affairs Leader Job Description Director, Regulatory Affairs 1. PURPOSE: Oversee process of preparing new or modified products for submission to FDA for approval. Manage process through to approval, including development of regulatory strategies and establishment of test procedures. Ensure compliance with all U.S. and international regulatory requirements pertaining to product approval, marketing, and labeling.
2. EDUCATION / EXPERIENCE REQUIRED: BS degree in scientific discipline required. MS, PhD, or JD desirable. Minimum 5 - 7 Years comprehensive regulatory experience. 3. KEY JOB RESPONSIBILITIES: Directs coordination, compilation and submission of Pre Marker Notification (510K), Pre Market Approval (PMA). Manages the preparation of IND amendments, NDA supplements and IND and NDA annual reports. Ensures rapid and timely approval of new products and Regulatory support for marketed devices and diagnostic products. Directs preparation of responses to FDA questions and other Regulatory correspondence. Ensures preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Interacts extensively with FDA personnel in order to expedite approval of pending applications and resolve regulatory matters. Provides Regulatory guidance to project teams. Conducts product labeling/advertising review. Provides guidance to subordinate manager(s) or high level staff specialists, based on organizational goals and company policy. 4. SUPERVISORY RESPONSIBILITIES: Subordinates: Managers and professional staff. 5. ENVIRONMENTAL, HEALTH AND SAFETY: All managers shall proactively support company’s Environmental Health and Safety (EHS) Policy by providing the necessary resources and giving equal emphasis with other functions such as production and quality. It is the duty of every manager to:
· Ensure implementation of safety and environmental procedures, guidelines and standards · Evaluate employee compliance and enforce established safety and environmental procedures and rules · Create a safe environment in work areas, and recognize and reward safety activities and good safety performance · Provide training to employees when: o Hired, o Transferred, o New substances, processes, procedures or equipment are introduced to the workplace and represent a new hazard · Measure safety performance and hold persons accountable for activities and results · Ensure that incidents are investigated to determine root cause, and that corrective actions are taken · Ensure employees wear required protective equipment · Ensure EHS inspections are conducted monthly and corrective actions are implemented Job Category Operations Management Country - State/Province United States - California City Carlsbad
