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Senior Regulatory Affairs Specialist

Date: Dec 2, 2018

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  19541  

 

Join Terumo BCT as we unlock the potential of blood. We are the world leader in blood component technology, delivering products, services and solutions for customers and their patients worldwide. Through collaboration with our customers and a commitment to innovation, we are the only company with the unique combination of apheresis, manual and automated whole blood processing and pathogen reduction technologies coupled with robust technology, innovation and core competencies in therapeutic apheresis, cell collections and cell processing.

 

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.

 

In order to support the development of the Mirasol Pathogen Reduction Technology (PRT) System for Whole Blood, Terumo BCT is seeking a Senior Regulatory Affairs Specialist to support ongoing clinical studies and a first-in-kind Pre-Market Approval (PMA) of this Class III medical device to the US FDA. Working under broad supervision, assists in fulfilling Regulatory compliance requirements for more than one product/project by applying a thorough understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices, pharmaceuticals or biologics.

 

ESSENTIAL DUTIES

  • Expert in regulations in order to author entire Regulatory dossiers and identify and suggest potential strategies that can be used to address the gaps.
  • Identifies and defines contents for Regulatory submissions/dossiers.  Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
  • Provides Regulatory support to life cycle project teams at any point in the development process.
  • Interacts with and/or directs others in interacting with Regulatory and Certification authorities.
  • Identifies the need for, prepares, and conducts Regulatory related training for the business.
  • Represents functional area within specific business area to provide guidance and recommendations for issues that may arise.  May require approvals from management.
  • Assumes major responsibility for one or more major Regulatory Affairs areas based on past experience and a broad base of knowledge and understanding of regulatory requirements Identify problems and significantly improve, change or adapt existing methods and techniques drawing from personal experiences and feedback
  • Reviews device labeling , advertising materials and product manufacturing changes for compliance with global regulations; analyses and recommends appropriate changes.
  • Advises business management of regulatory and certification issues in a pro-active manner.
  • Exercises considerable judgment in determining approach and then researches, prepares, and submits required regulatory documents including those in response to documents issued by regulatory authorities.  Responsibility includes both preparation of these documents in compliance with U.S. and international regulatory authorities and providing guidance to Regulatory staff in the preparation of them.
  • Reviews submissions to identify adequacy of sections, overall content of submissions and completeness of submission and consistency of story.
  • Collaborates with individuals at different levels and develops, or is responsible for the development of either solutions to problems of limited complexity that affect diverse functional areas, or solutions to problems of moderate complexity that may affect a few functional areas.
  • Executes policies at direction of supervisor and makes recommendations for improvements within the organization.

 

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.

 

Experience

Minimum 7 years experience in Regulatory Affairs.

  • Pre-Market Approval (PMA) experience is required

 

Skills

  • In depth knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards.
  • Demonstrated success in the creation of regulatory submissions such as CE Mark for Class II-III products, IDEs, INDs, 510(k)s, NDAs, ANDAs.
  • Expert with Regulatory issues within a certain business area, product or geography.
  • Preferred expertise with medical device regulations such as: 21 CFR 820, ISO 13485, ISO 62304, ISO 60601-1 however expertise knowledge in pharmaceutical or biologic regulations and standards would be considered.
  • Apply previous regulatory experience to help ensure success of submissions.
  • Able to apply business insight and have ability to to understand  how product approval strategy interacts with business strategy.
  • Demonstrated ability to collaborate and think outside the box.
  • Highly qualified regulatory professional with intermediate understanding of and demonstrated experience working with/across multi-functions that are closely related.  May be recognized as an expert in regulatory affairs.
  • Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines.

 

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 required (up to once a quarter)

 

"Join forces with the industry leader to make a difference in the world of healthcare:

 

TERUMO PENPOL is part of the multi-billion dollar TERUMO Corporation, Japan and synergized with its Blood Management business, TERUMO BCT, U.S.A., we provide a comprehensive range of blood collection, storage and processing solutions for Blood Centers, Hospitals and Therapeutic Apheresis Centers in India and abroad. 

 

Headquartered in Thiruvananthapuram, Kerala, we are home to the best of talents in the industry and one of the largest manufacturers of blood bags in the world, with our high quality products touching the lives of patients in over 80 countries across the world.

 

True to our aim of contributing to the society through healthcare, our award-winning Corporate Social Responsibility initiatives serve as a reinforcement of our organizational values and culture. Firmly rooted in core values collectively termed as the ‘Associate Spirit’, our work culture fosters an environment conducive to growth and continuous learning. People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.

 

If you have a passion for innovation and a commitment to be the best at what you do, we invite you to be a part of our journey towards unlocking a better future for the patients we ultimately serve.' 


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