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Regulatory Affairs Manager

Date: Jan 3, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  22241  

 

JOB SUMMARY

Performs regulatory activities and is responsible to manage product registrations and submissions for  product lines and / or geographical areas.   Supports activities related tothe launch of new products, maintenance of existing products  and maintains regulatory compliance and regulatory systems for the company.

 

ESSENTIAL DUTIES

  • Develops, or is responsible for the development of, regulatory solutions to problems of moderate to intermediate complexity that may affect diverse functional areas of the business or company or unusual complexity in the function
  • Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross functional teams
  • Create new methods, techniques and/or processes across job areas or functions exerting  some influence on the overall objectives and long-range goals
  • Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
  • Represent specific business areas or geographies as the primary contact, interacting and creatingan ongoing, proactive relationship and collaboration with internal scientific, marketing, and engineering colleagues and/or regulatory authorities.  Coordinate activities with senior management team.
  • Responsible for overseeing regulatory compliance, development and timely national and international regulatory submissions, ensuring that all regulatory activities are conducted with the highest integrity and in an ethical manner
  • Reviews staff submissions to identify adequacy of sections, completeness and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed
  • Represent departmental function, acting  as primary interface with regulators, presenting strategies and negotiating solutions, and may lead and coordinate intra- and inter-company projects
  • Interprets, executes, and recommends modifications to operating policies at business level.  Will establish operating policies within specific business operating area and recommend policies that impact other areas.
  • Shares experience with most stages of product life cycle and concentrates on new product development and post-market applications of existing products
  • Communicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies to achieve timelines
  • Ensures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims
  • Acts as an effective regulatory consultant to management and other functions
  • Acts a leader who embodies regulatory expertise as well as business acumen with a positive corporate mindset

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Such as a Masters in Regulatory Affiars or MBA.

 

Experience

Minimum 8 years experience in Regulatory Affairs and 1 year of direct or indirect management experience preferred

  • PMA experience a plus
  • Direct experience in gaining FDA or Notified Body approvals for devices or drugs or biologics
  • Experience in an environment where skills in negotiation, listening, persuasion, collaboration, compromise and analytic based judgement is used daily

Skills

  • Demonstrated success in the management of regulatory submissions such as as CE Mark for Class II-III products, IDE’s, IND’s, 510(k)’s, NDA’s, ANDA’s
  • Knowledge of technical aspects of regulatory profession, combined with scientific understanding and project management skills
  • Understands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges and ability to resolve them through collaboration
  • Recognized as an emerging authority within the business or function with broad understanding of and experience working with multiple functions that are unrelated
  • Able to manage ambiguity and have ability to fill gaps with alternative data
  • Expert with Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures
  • Possess business insight and have ability to understand how product approval strategy interacts with business strategy, may involve in creating/ proposing such strategy
  • Nimble learning and able to actively seek out relevant legislation and competitive information on product lines
  • Must be results oriented and decisive. Failure to obtain results or arrive at approproiate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.
  • Demonstrated analytical and creative thinking skills and the ability to solve complex problems
  • Able to mentor and develop talent of direct reports
  • Ability to interact with diplomacy and tact while maintaining appropriate assertiveness
  • Willingness to take ownership and accept responsibility, ensuring accountability for actions and decisions
  • Must be detail oriented, well organized and able to work both independently and in teams
  • Knowledge and use of relevant PC software applications and skills to use them effectively
  • Demonstrated ability to communicate effectively both verbally and in writing

 

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) desired.

 

-Or-

 

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

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

 

Additional Physical Requirements

Some travel may be required (5-10%)

 

#LI-CS1  *CB*

 

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 BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

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