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Mgr Regulatory Affairs

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Date: Jun 22, 2022

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  29366  

 

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. 

Regulatory Affairs Manager

 

JOB SUMMARY

Performs regulatory activities and is responsible to manage Associates and product registrations and submissions.   Leads activities related to the launch of new products, maintenance of existing products and maintains regulatory compliance and regulatory systems by applying a thorough understanding of regulatory standards and regulations for medical devices, pharmaceuticals, or biologics.

 

ESSENTIAL DUTIES

  • Provide direction, leadership and coaching to RA Associates to meet schedules and resolve technical or operational problems. Becomes actively involved in daily operations to meet schedules or to resolve complex problems.
  • Lead the development of strategic input and provide technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations.
  • Manage Associates to development of regulatory strategies.
  • Provide technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations.
  • Responsible for preparation or review of regulatory submissions.
  • Represent regulatory on teams to develop regulatory strategies, including reviewing and influencing the various specifications and testing plans/reports, providing regulatory feedback and guidance throughout the product lifecycle.
  • Manage multiple projects and prioritize tasks on day-to-day basis to meet project schedules.
  • Identify the need for new or modified regulatory procedures, SOPs, and leading in the development and implementation.
  • Represent specific business areas or geographies as the primary contact, interacting and creating an ongoing, proactive relationship and collaboration with internal scientific, marketing, and engineering colleagues and/or regulatory authorities.  Coordinate activities with senior management team.
  • Maintain current and grow regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Interpret the intent of regulations and policies and provide such information to teams and management.
  • Communicate regulatory strategy effectively to applicable departments, senior management, regulators, and regulatory agencies to achieve timelines
  • Review advertising and promotional materials for compliance with global regulations; analyses and recommends appropriate changes.
  • Act as an effective regulatory consultant to management and other functions
  • Act 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.

 

Experience

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

  • 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

  • Must have excellent written and verbal communication skills 
  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities
  • Must be able to prioritize and handle several projects concurrently
  • Must be able to provide leadership and mentoring skills and/or supervision to less experienced regulatory personnel
  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
  • Must have authored a regulatory submission in the US, EU and/or Canada that was submitted for regulated agency review.
  • Must have in-depth working knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards and the ability to apply knowledge to submissions reviewed by a regulated agency.
  • Able to apply business insight and have ability to understand how product approval strategy interacts with business strategy.
  • Demonstrated ability to collaborate and think innovatively (outside the box).
  • Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines.
  • Apply previous regulatory experience to help ensure success of submissions. Understands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges and ability to resolve them through collaboration
  • Able to manage ambiguity
  • Ability to develop strategy to fill gaps where alternative data could be accepted
  • Ability to understand and resolve Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures
  • Must be results oriented and decisive.
  • Demonstrated analytical and creative thinking skills and the ability to solve complex problems
  • 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

 

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) preferred.

-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%)

 

 

Target Pay Range:  $117,200.00 to $146,500.00  -  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:  15.0%

 

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.


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