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Director of Quality Assurance and Regulatory Affairs

Cancer Genetics, Inc. (CGI) is an emerging leader in the field of personalized medicine, offering diagnostic products and services that enable precision medicine in the field of oncology. We believe our employees are the key to delivering on our promise, and fulfilling our mission in the marketplace. Developing a diverse, collaborative, inclusive and dynamic workplace is core to attracting and retaining people who want to innovate in cancer diagnostics, make a difference in patient outcomes and make oncology their life's work. The Director of Quality Assurance / Regulatory Affairs will be responsible for the following:  Direct the growth and continued improvement of the quality system   Direct the document control and training compliance system for the company   Develop company regulatory strategy   Assure executive staff is informed of any issues that may adversely impact the Quality System   Train and mentor staff to ensure appropriate knowledge base to support teams   Aid in the establishment of processes and procedures to ensure departments and Company are in compliance with relevant guidance and     requirements   Provide strategic Regulatory Affairs positioning to R&D and colleagues   Manage team in the preparation of registration packages and responses to deficiency letters; negotiate submission data requirements and  deliverable dates with regulatory authorities and cross functional teams   Stay current on latest trends and guidance   Serve as Regulatory Affairs representative on launch and pending submission management meetings  Qualifications: Bachelor's degree in a life sciences, chemistry, or related discipline. Advanced degree preferred  6 to 8 years of experience in Quality Assurance / Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment.  Experience with health authority meeting preparation  Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions.  Ability to successfully manage multiple projects to deadlines  Experience with regulatory intelligence activities and registration databases to support product approval strategies         Equal Opportunity  / Affirmative Action Employer
Salary Range: NA
Minimum Qualification
5 - 7 years

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