Job Title: Director of Regulatory Affairs & Quality Assurance
Summary: Report to the President. Lead overall strategy for quality assurance and regulatory affairs. Act as a liaison between the company and various governmental and regulatory agencies.
Major Responsibilities: Develop, implement, and maintain quality assurance programs, policies, processes, procedures ensuring performance and quality of laboratory product.
Provide leadership, establish quality and regulatory procedures that link to and support the overall laboratory’s objectives.
Provide expertise and advise president and Laboratory Director on significant compliance issues. Collaborate with the laboratory’s QA/RA team.
Coordinate and lead regulatory inspections as well as all communicate with regulatory and certification agencies. Provide technical guidance during internal audit activities.
Act as in-house consultant on quality issues. Provide constructive guidance in finding solutions to QA , QC and regulatory problems.
Assess compliance and quality systems and provide expertise and support for corrective actions, improvement, and readiness for inspections.
Work cooperatively with various governmental agencies in the development of the laboratory policies that allow to operate in a compliant manner.
Responsible for regulatory submissions such as licenses and ensure tracking of all regulatory communications, especially those related to compliance. Monitor and ensure new lab test materials are compliant with CLIA regulations.
Be a resource person to the laboratory when there is a need for document review and compliance assessment.
Serve as a member of the Senior Management Leadership Team.
Qualifications: Master degree in Science, Healthcare, or relevant field or equivalent combination of education and experience required. A minimum of 5-7 years experience in quality assurance and regulatory affairs within a complex regulated diagnostic, biotech, pharmaceutical or similar organization. Must demonstrate successful interfacing with CLIA and other regulatory agencies. Have the ability to manage projects from submission to approval in a challenging regulatory environment.
Excellent written/oral communication skills are a must.