Share this Job

Regulatory Affairs Sr Specialist

Apply now »

Date: Nov 20, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  28248  

 

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 SUMMARY

Working under limited 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. Such as a Masters in Regulatory Affairs.

Experience

Minimum 6 years’ experience in Regulatory Affairs.

  • PMA experience a plus
    Previous relevant experience and/or combined with a Masters in Regulatory Affairs may also be considered.
    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  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, traverse, 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)

 

Target Pay Range:  $85,000 to $107,000  -  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:  10.0%

 

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. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.


Nearest Major Market: Denver

Job Segment: Medical, Engineer, Pharmaceutical, Business Manager, Advertising, Healthcare, Engineering, Science, Management, Marketing