Director, Regulatory Affairs - Compliance Systems and Labeling

Terumo BCT, Inc.-posted 2 days ago
Full-time • Director
Hybrid • Denver, CO
5,001-10,000 employees
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At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours. 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.

  • 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 modeling, leadership technique, production methods, and coordination of people and resources.
  • Experience working in Quality or leading a Quality team is preferred.
  • 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 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 such as the EU and Canada 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 capable of communicating with a diverse range of individuals.
  • Must be detail oriented, well organized and able to work both independently and in teams.
  • Professional education in Regulatory Sciences desired with regulatory certification a plus.
  • Experience with both sterile disposables and electro-mechanical medical devices with embedded software preferred.
  • Knowledge of the software in medical device regulations preferred.
  • Work with drug/device combination products is desired.
  • Experience working in Quality or leading a Quality team is preferred.
  • Regulatory Affairs Professional Society (RAPS) Certification (US and EU and/or Canada) or other geographic regulatory certification preferred.
  • At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
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