Director, Regulatory Affairs – Compliance Systems and Labeling

DUTIES AND RESPONSIBILITIES

• Provides 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.

• 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.

• 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 of representing unique technologies to regulatory authorities and gaining timely approvals is critical. Work with drug/device combination products is desired.
• Demonstrated effective leadership and strategic planning skills, in environments where regulatory guidelines have not been developed and where creativity can impact approval timelines.
• Experience working closely with clinical experts in all stages of clinical trials.
• Experience in regulatory compliance requirements desired (Health Hazard Evaluations, Removals and Corrections, Adverse Event Reporting, Promotional Material review, etc.).
• Direct experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources…