Associate Director OR Director of Regulatory Affairs, Medical Devices - Combination products – Balance between Operations and Strategy – Innovative, bleeding edge product. – San Diego Tristaff is partnering with this leader in vaccine product development, with research and engineering facilities in San Diego, CA. This is your opportunity to be a key contributor in the development of a new generation of vaccines, DNA vaccines, to treat and prevent cancers and infectious diseases. These vaccines are designed to provide broad cross-strain protection against both known and newly emergent strains of pathogens such as influenza. These vaccines, in combination with proprietary delivery devices, have been shown to be safe and generate significant immune responses. My client’s clinical programs include HPV/cervical dysplasia and cancer (therapeutic), avian flu (preventive), and HIV vaccines (both preventive and therapeutic). The Associate Director/Director, Regulatory Affairs, Medical Devices will assist the Senior Director in maintaining compliance with internal SOPs, local, regional, national, and international regulatory laws, standards, and regulations. The Associate Director/Director, Regulatory Affairs, Medical Devices will have a broad spectrum of responsibilities spanning regulatory submissions, health authority interactions, compliance and internal advisory activities. Minimum Requirements: • Bachelor/Master’s degree in life science or related area required • Area(s) of expertise desired: Biology, Immunology, Bioengineering, Cell or Molecular Biology. Experience with vaccines highly preferred • A minimum of 10 years in regulatory affairs with a minimum of 5 years in medical devices • Experience and knowledge of the relevant current requirements for medical device or combination product submissions to US FDA and prior interaction or exposure with other key regulatory authorities (e.g. EMEA, EU competent authorities, APAC regulatory agencies) Essential Requirements: • Excellent oral and written communication, interpersonal and organizational skills, and attention to detail • Ability to consistently meet tight timelines and deadlines Ability to interact effectively with management and prioritize multiple projects • Technical proficiency, effective problem solving and critical thinking skills • Ability to work in a team environment Jill Martinelli Director of Technical Recruitment TriStaff Group | San Diego, CA 92122 Phone 858.597.0845 | Cell 858.220.1282 jill@tristaff
Posted on: Fri, 11 Jul 2014 15:35:47 +0000
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