Overview

Director, Regulatory Affairs - Compliance Systems and Labeling As Director of Regulatory Affairs Compliance Systems and Labeling, you'll direct regulatory and labeling activities for Terumo Blood and Cell Technologies and collaborate with senior teams to define strategy and compliance programs. You'll play an integral part in launching new products, supporting established lines, and driving initiatives that ensure success across the entire lifecycle. If you thrive on strategic influence and want to champion quality and compliance at a global scale, we'd love to connect with you. DUTIES AND RESPONSIBILITIESProvides strategic direction and operational leadership for regulatory affairs in a business area or region.Provides strategic direction and operational leadership for global labeling.Develops and communicates effective regulatory strategies, to meet established business goals.Provides intentional influence to ensure a robust, day-to-day 'culture of quality and compliance' exists in the business area or region.Acts as an internal champion for quality and regulatory initiatives aimed at improving business systems and compliance.Works closely with other senior level colleagues within and outside of the company to resolve highly complex and sensitive issues.Fosters an ongoing proactive relationship with internal R&D, Clinical, Scientific, Quality, Legal, Manufacturing and Marketing colleagues.Influences internal customers as necessary to ensure successful strategy implementation.Directs the professional growth of professional staff by providing individualized guidance, training and supervision.Participates in Management Teams for business areas.Develops Regulatory presentation for Regulatory section of Management Review and participates in the meeting.Oversees the development of 510(k)s, IDEs, PMAs, CE Technical Files, CE Design Dossiers, NDA's and ANDA's and other international regulatory submissions.Acts as primary interface with applicable regulatory bodies, presenting strategies and technology communications effectively.Acts as Regulatory PRRC and performs required PRRC activities.Ensures that all regulatory activities are conducted with the highest integrity in an ethical, legal and compliant manner.Provides support for development of new products, from design inputs including clinical and regulatory specifications through comprehensive design validation support.Determines the adequacy of new products/processes prior to and following commercial distribution.Works closely with Quality Assurance to ensure that the Quality Management System is maintained for effectiveness in accordance with applicable standards and regulations.Identifies areas of regulatory or compliance risk and develops mitigating strategies.Directs compliance programs such as the Standard Assessment program, UDI compliance, and State License program as well as Regulatory Operations.Identifies areas of regulatory, or compliance risk and develops mitigating strategies and works to implement solutions cross-functionally.Monitor and drive solutions for changes in regulatory environment that have the potential to impact Terumo BCT business and participate in industry groups for pro-active engagement. MINIMUM QUALIFICATION REQUIREMENTSEducation: Four-year college degree required and an advanced degree in the physical sciences considered a plus.Professional education in Regulatory Sciences desired with regulatory certification a plus.Experience: Minimum of 10 years regulatory experience with increasing responsibility in the medical device or pharmaceutical industry. Experience with both sterile disposables and electro-mechanical medical devices with embedded software preferred. Knowledge of the software in medical device regulations preferred. Experience with pharmaceutical submissions (NDA/ANDA in eCTD format) or medical device submissions (510(k), PMA, CE mark, etc.). Minimum 5 years managerial experience with multiple direct reports. A demonstrated track record