Associate Director, Regulatory Affairs, Medical Devices -EU at Inovio in San Diego, California

Job Description:

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce an efficacious, robust and tolerable immune response. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.

Job summary

The Associate 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 Associate Director has a broad spectrum of responsibilities spanning regulatory submissions, health authority interactions, compliance and internal advisory activities.

Essential job functions and duties

Regulatory Submissions:

• Organize and compile device regulatory submissions and other correspondence to international and US regulatory agencies that may be considered moderately complex in support of INOVIO's pharmaceutical/medical device combination product in Phase I-III programs


• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained


• Develop strategies for device regulatory submissions to health authorities worldwide


• Manage communications with Notified Body; and European Authorized representative to facilitate device registrations, vigilance reporting etc. Support manufacturing in establishing economic operators in Europe. Thorough knowledge of conformity assessment process for CE Marking. Create and maintain technical documentation.


• Define and recommend labelling content for use of devices globally


• Maintain up-to-date knowledge, identify and monitor applicable standards and guidances, communicate with cross-functional team for timely implementation


• Manage communications with CROs and provide guidance for completion of global Clinical Trial Applications and regulatory submissions. Knowledge and experience in Latin America, Asia-Pacific, EU and North America desirable


• Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications. Develop expertise in electronic common technical document (eCTD) guidances and practices

Health Authority Interactions:

• Interact with key personnel in regulatory entities to ensure the review and approval of development plans, the timely resolution of issues, and the approval of applications

Regulatory Compliance:

• Participate in 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, directives and standards that impact INOVIO's products and operations to 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 international device regulatory plan and provide 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

Minimum requirements

• Bachelor/Master's degree in engineering, science or a related area required


• A minimum of 8 years in regulatory affairs with a minimum of 5 years in medical devices


• Area(s) of expertise desired: Medical device or combination product regulatory affairs experience required. Electromechanical device experience desired.


• 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. Notified Bodies, EU competent authorities, APAC regulatory agencies, etc.).


• Experience and knowledge of global labelling requirements; ability to interpret requirements and provide recommendations for the development and maintenance of labelling materials


• Strong regulatory writing, design control and quality system knowledge required. Knowledge of submissions tools and processes desired.


• Technical proficiency, effective problem solving and critical thinking skills


• Excellent oral and written communication, interpersonal and organizational skills; attention to detail


• Ability to consistently meet tight timelines and deadlines


• Ability to interact effectively with management and prioritize multiple projects


• Ability to work in a team environment

Disclaimer

INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.

Important notice to employment businesses/agencies

INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.