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Director of Regulatory Affairs

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Date: Apr 15, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  27245  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

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.

 

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. Consider joining our team and unlock your potential.

 

JOB TITLE:  Director – Global Regulatory Affairs

 

JOB SUMMARY

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 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.
  • 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 or compliance risk and develops mitigating strategies.

 

MINIMUM QUALIFICATION REQUIREMENTS

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

  • 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 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.

 

Certificates, Licenses, Registrations:

  • Regulatory Affairs Professional Society (RAPS) Certification (US and EU and/or Canada) or other geographic regulatory certification preferred.
     
    Equipment:
  • Expertise in Microsoft Office applications is required.

 

ADDITIONAL INFORMATION

  • There will be occasional requirement to work outside of normal business hours, consistent with other Director-level positions.
  • Some international travel will be required (10-15%)

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

  

 

 

Target Pay Range:  $136,200.00 to $170,200.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  40.0%

 

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.

 

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect – Appreciative of others
    • Integrity – Guided by our mission
    • Care – Empathetic to patients
    • Quality – Committed to excellence
    • Creativity – Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

 

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

 

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.


Nearest Major Market: Denver

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