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Director, Regulatory Affairs, Medical Devices

Company: Inovio Pharmaceuticals
Location: San Diego
Posted on: September 23, 2022

Job Description:

About INOVIOINOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from infectious diseases, cancer, and diseases associated with HPV. Our DNA medicines in development are delivered using our proprietary smart device to produce immune responses against targeted pathogens and cancers. For more information, visit www.inovio.com . Job summaryThe Director, Regulatory Affairs, Medical Devices provides regulatory guidance and oversight to ensure INOVIOs 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

  • Provide regulatory expertise and guidance on regulations and requirements. Strategically interpret, plan, and communicate requirements to ensure regulatory authorizations are obtained
  • 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
  • Develop and maintain global regulatory strategy for device during product life cycle. Conduct regulatory intelligence to identify country specific regulations and requirements for Inovios products including product labeling
  • Provide interpretive analyses of standards, regulatory guidance documents, regulations, proceedings, or directives that impact INOVIOs products, operations and development programs
  • Review and approve data and documentation required for medical device/pharmaceutical combination product regulatory submissions. Participate in cross-functional clinical study teams
  • Provide input, review and recommendations for device design inputs & outputs, verifications and validations. Provide regulatory support to product development teams in the application of key technical standards for Electrical Safety (IEC 60601), Software life cycle processes (IEC 62304), Usability Engineering (IEC 62366), Packaging and Sterilization standards
  • Oversee organization and compilation of device regulatory submissions and other correspondence to US and international regulatory in support of INOVIOs pharmaceutical/medical device combination products in Phase I-III programs. Provide oversight to direct reports. Manage work through external consultants as needed to maintain throughput
  • Maintain up-to-date knowledge of the data, information, and formats required for inclusion in these applications
  • Participate in internal and external quality system audits. Collaborate with INOVIOs Quality Assurance and Engineering groups for maintaining compliance with applicable regulatory standards (e.g. FDA, MDR, ISO 13485 & ISO 14971)Minimum requirements
    • Bachelor/Masters degree in engineering or a related area required
    • 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. EU Notified Bodies, Latin America 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 environmentDisclaimerINOVIO 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/agenciesINOVIO 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.Powered by JazzHR

Keywords: Inovio Pharmaceuticals, San Diego , Director, Regulatory Affairs, Medical Devices, Healthcare , San Diego, California

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