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Senior Manager, Regulatory Affairs

Date: Aug 18, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23181  

 

Develops objectives and plans for major portions of the Regulatory and its intersection with Manufacturing, Operations, Quality, and Commercial. Controls function or functions to achieve an end result that supports business and corporate goals.  Leads activities related to the 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 that may affect diverse functional areas of the business or company or unusual complexity in the function to improve overall effectiveness of regulatory affairs and its intersection with other departments
  • Analyze changing business, internal customer and staffing needs and develops and directs implementation of plans to achieve cross-functional short and long term business goals that support overall business and corporate objectives
  • Interprets, executes, and recommends modifications to operating policies at business level within and outside area of responsibility.  Will establish operating policies within specific business operating area and recommend policies that impact other areas.
  • Bring together multiple concepts across job areas to define a new direction or a significant advancements to regulatory processes, prioritizing recommendations on how to achieve regulatory timelines and/or regulatory compliance
  • Represent multiple business areas or geographies as the primary contact.  Interacts with business area management teams and/or regulatory authorities.  Recommends and coordinates specific actions with senior management team.
  • Oversees preparation and submission of regulatory documents, acts as internal and external consultant on regulatory issues and leads regulatory and certification inspections
  • Works with industry groups, elected officials, and governmental personnel to advance company interests
  • Hands-on development of regulatory submissions such as CE Mark for Class II-III products, IDE’s, IND’s, 510(k)’s, NDA’s, ANDA’s
  • Leads regulatory inspections and interacts with regulatory bodies on compliance issues
  • Monitors, reports, and comments on changes in U.S. and international regulatory policies and issues through monitoring of new regulations, guidelines, policies, and standards; trade papers, and journals; membership and participation in professional organizations; and attendance of regulatory seminars and training programs
  • Participates, promotes and leads subordinate participation on cross-functional and/or inter organizational teams
  • Responsible for reviewing and approving submissions, arguments, positions, and strategies
  • Involved in creating/ proposing product approval strategy

 

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 Affairs or MBA.

 

Experience

  • Minimum 10 years experience in Regulatory Affairs and 3 years direct regulatory management experience, including:
  • Leading regulatory inspections and interacting with regulatory bodies on compliance issues
  • Developing quality and productivity goals and measures
  • Commercial partnership experience – understanding how to balance regulatory compliance with business needs
  • Strategic regulatory positioning to ensure best probability of success in a timely manner
  • Actively seeking out relevant legislation and competitive information on competitors and been involved in ideas to influence legislation

 

Skills

  • Recognized as an expert within the company with diverse and varied understanding and experience working with multiple functions that are unrelated
  • Working knowledge of medical and therapeutic medical devices or pharmaceuticals or biologics
  • Able to manage ambiguity and have ability to fill gaps with alternative data
  • Expert across multiple business areas, able to manage complex projects, and are able to get results within a matrix organization
  • Has resourcefulness and ability to drive for results to work on new, high challenge products, new platforms or projects across business areas
  • Recognized, internally and externally, as having exceptional expertise and vision in Regulatory and the intersection with other departments
  • Broad knowledge of management of people, complex projects, and regulatory affairs
  • Demonstrated effective leadership, managerial, and strategic planning skills
  • Possess financial acumen and strategic mindset
  • Ability to develop talent and drive engagement
  • Demonstrated project management skills
  • Extensive knowledge of U.S. and international medical device regulations including quality systems regulation international standards
  • Exceptional understanding of quality management techniques and theories
  • Demonstrated ability to effectively work with regulatory agencies to advance company interests
  • 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.

 

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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