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Dir Regulatory Affairs

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Date: Sep 1, 2021

Location: Brussels, BE

Company: Terumo BCT, Inc.

The Director of Regulatory Affairs will direct regulatory activities for a business area or region.  The Director will work with business area or regional management teams to help set business strategies and drive regulatory strategy and compliance programs for the medical devices and/or pharmaceuticals marketed by the company.  The Director will play an integral role in helping launch product lines, manage mature product lines and ensure their ultimate success.

DUTIES AND RESPONSIBILITIES

  • Provides strategic direction and operational leadership for regulatory affairs in a business area or region.
  • 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 I&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 on Management Teams for business areas and/or regions.
  • 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.
  • 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, environmental 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.
  • Act as Person Responsible for Regulatory Compliance (PRRC) and EU Authorized Representative (if applicable).

Education

  • 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 working in Quality or leading a Quality team is preferred. 

 

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 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 review, etc.)
  • Direct experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

 

Skills

  • Ability to solve practical problems and interpret and communicate complex regulatory requirements in a manner that allows maximum product flexibility without compromising regulatory compliance.
  • Demonstrated ability to select, manage, motivate, lead, influence and develop regulatory skills in coworkers of varying levels of experience. 
  • Capacity to define and communicate regulatory challenges and provide guidance to top management by developing and implementing positive and proactive solutions. 
  • Excellent English written and oral communication skills and a proven ability to communicate effectively.  Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies.
  • Demonstrated ability to interact productively and to effectively influence peers, external colleagues and senior management.
  • Willingness to take ownership and accept responsibility for actions and decisions.
  • Regulatory expertise complemented by strong operational, logistical, communication and business skills.
  • Knowledge of current US and non-US regulatory requirements and trends affecting medical devices and pharmaceuticals.
  • Ability to help management team balance regulatory requirements with business requirements and identify solutions to meet both sets of needs.
  • Strong interpersonal and conflict management skills, maturity and good judgment and be capable of communicating with a diverse range of individuals.
  • Must be detail oriented, well organized and able to work both independently and in teams.

 


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