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Sr. Director, Regulatory Affairs

Company: Terumo Cardiovascular Systems Corporation
Location: Aliso Viejo
Posted on: April 3, 2021

Job Description:

The Sr Director, Regulatory Affairs position is responsible for managing and providing strategic and tactical direction for Regulatory Affairs activities company-wide reports. Job duties:

  • Drives implementation of and continued compliance to global regulatory requirements, interprets and applies pertinent laws and regulations governing company products to meet business objectives.
  • Leads development, implementation and maintenance of regulatory processes at a company-wide level.
  • Leads WW regulatory submissions for Class II and Class III medical devices.
  • Supports the SVP, WW Regulatory Affairs, Clinical Research and Quality in developing regulatory strategies and application of the strategies to align with the business plans for a particular product.
  • Actively works with R&D, Clinical Research, Marketing, and Quality to ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications for US and International regulatory submissions.
  • Serves as main contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies when needed, directly or in coordination with local country representation.
  • Demonstrates sound understanding of related fields (e.g., manufacturing, product /process development, quality assurance) and the ability of diverse problem solving.
  • Monitors the regulatory environment regionally/globally and provides assessments for the impact of new and changing regulations on the company's areas of interest. Ensures new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training.
  • Leads representation of Regulatory on project teams and partners with the cross functions on the team to ensure alignment of regulatory strategy and plans with the team objectives.
  • Supports and contributes into editing/revising Standard Operating Procedures.
  • Develops and supports training for global regulatory processes and system implementations.
  • Builds team cohesiveness by leading, influencing, mentoring and motivating team members.
  • Performs additional responsibilities as assigned. Qualifications
  • Minimum BA/BS degree in a scientific or technical discipline or other relevant field of study.
  • Fifteen (15) years of professional regulatory experience in medical devices.
  • Must have a minimum of five (5+) years of supervisory/management experience.
  • Knowledge of medical devices regulations, trends and developments impacting company operations and products worldwide.
  • Hands-on experience with 510(k), PMA and Technical File/Design Dossier submissions (PMA experience is essential).
  • Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
    • Effective facilitation skills to motivate multi-functional groups and proven effective leadership skills to guide and mentor team members.
    • Demonstrated ability to work effectively with a variety of work groups including multi-ational teams to assure conformance to regulatory requirements, internal processes and procedures.
    • Excellent interpersonal communication, collaborative teamwork, and negotiation skills.
    • Excellent communication skills both verbal and written.
    • Demonstrated project management and organizational skills.

Keywords: Terumo Cardiovascular Systems Corporation, Aliso Viejo , Sr. Director, Regulatory Affairs, Executive , Aliso Viejo, California

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