Vice President Head Of Regulatory Affairs Indianola Pennsylvania United States

Job description

The primary responsibilities of this role, Vice President, Head of Regulatory Affairs Medical Devices, Radiology are to: VACC Leadership: Act as a VACC (Visionary, Architect, Catalyst, Coach) leader. Be a role model for embracing and actively championing the DSO operating model and behaviors, empowering teams to drive outcomes, take ownership, and act with agility. Provides regulatory and scientific input and expertise to R&D teams regarding strategic MD development decisions, including the robust assessment of external opportunities. Contributes to medical and scientific dialogue with regulatory health authorities globally. Established ability to build effective relationships with health authorities. Effectively leads, trains, and coaches a home team of Global RA colleagues who provide the regulatory expertise and leadership of the Radiology R&D portfolio. Ensures talent management, succession planning and people development for the Regulatory Affairs MD group. Contributes as a member of the Radiology RA LT to the overall Radiology RA vision and strategy. * Bachelor's degree Regulatory / Scientific expertise with a deep understanding of Medical Device regulations. In-depth knowledge of the Regulatory Affairs environment and requirements and proven track record of successful approvals in device areas. Knowledge of global development processes for devices and establishing relations with Health Authorities, Notified Bodies and distributors. Strong working knowledge of Quality System Regulations, Medical Device Regulations, international regulations, FDA guidance, and international standards. Expertise in FDA 510(k) and EU medical device /technical documentation requirements. Longstanding relevant professional experience in R&D, Quality, or Regulatory Affairs within the Health Care industry. Outstanding track record of leading teams and managing Global Regulatory Experts within agile or matrixed environments. Ph.D., M.D., P.Eng. or PharmD Regulatory device experience; or Master's with Regulatory device experience and managerial experience Talent Management: Ability to attract, develop, and retain top talent.