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Biotechnology, Clinical Trials, Medical Device, Quality/Risk Management
4 Year Degree
The Director, Regulatory Affairs, Medical Devices provides regulatory guidance and oversight to ensure Inovio’s compliance with internal SOPs, local, regional, national, and international regulatory laws, standards, and regulations. The Director, Regulatory Affairs, Medical Devices has a broad spectrum of responsibilities spanning regulatory submissions, health authority interactions, compliance and internal advisory activities.
Essential job functions and duties
Set strategy for device regulatory submissions to health authorities worldwide
Oversee organization and compilation of device regulatory submissions and other correspondence to US and international regulatory agencies that may be considered moderately complex in support of Inovio’s pharmaceutical/medical device combination product in Phase I-III programs
Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications
Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained
Health Authority Interactions:
Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of applications
Effectively plan, organize, and conduct formal meetings/teleconferences with regulatory agencies for designated programs
Conduct internal compliance audits in accordance with applicable regulatory standards (e.g. FDA, MDD, ISO) in preparation for external quality system audits
Participate in external quality system audits with Inovio’s Quality Assurance and Engineering groups
Review and provide interpretive analyses of complex regulatory guidance documents, regulations, proceedings, or directives that impact Inovio’s products and operations to Senior Director, Regulatory Affairs and management team for assessment of potential impact on development programs
Internal Advisory Activities:
Provide input and recommendations for device design and process verification and validation activities with Inovio’s Manufacturing, Engineering and Quality groups
Develop device regulatory strategic plan and provides guidance to cross-functional project team.
Review and approve data and documentation required for medical device/pharmaceutical combination product regulatory submissions
Provide input into development of regulatory and quality systems
Participate on project teams and provide device regulatory updates and summaries to management
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. EMA, EU competent authorities, APAC regulatory agencies, etc.)
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
Internal Number: 435
About Inovio Pharmaceuticals
Inovio is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic DNA technology targeted against cancers and infectious diseases. Inovio's proprietary technology has been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio Corporation, GeneOne Life Science, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency, National Institutes of Health, National Institute of Allergy and Infectious Diseases, National Cancer Institute, HIV Vaccines Trial Network, Walter Reed Army Institute of Research, Medical CBRN Defense Consortium (MCDC), The Wistar Institute, and the University of Pennsylvania. For more information, visit www.inovio.com.