Regulatory Affairs Specialist

Requisition ID:  33076  

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. For Terumo, for Everyone, Everywhere.

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. Advancing healthcare with heart.

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. Join us and help shape wherever we go next. You create your future and ours.

As a Regulatory Affairs Specialist you will play a pivotal role in shaping the future of healthcare and life sciences. As a key member of our dynamic organization, you will navigate the complex landscape of regulatory compliance, ensuring that our innovative products and therapies meet all legal and quality standards. Your expertise will drive the timely approval of new treatments, ensuring they reach patients in need. If you are a detail-oriented, passionate individual with a strong understanding of regulatory processes, this is your opportunity to make a meaningful impact on global healthcare while advancing your career in a collaborative and rewarding environment.

ESSENTIAL DUTIES

• Research, and identify product classification and contents for global regulator submissions. 
• Coordinates or leads preparation of documents for internal audits and inspections.
• Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions or notifications, as required, by geography. 
• Leads global regulatory assessment for product or labeling changes.  Compiles feedback from regions. Summarize collected information into a regulatory strategy.
• Develop and maintain product technical files.
• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies for changes.
• Works with manufacturing, engineering, quality, labeling, clinical affairs and other functional groups on Regulatory compliance issues.
• Applies standard procedures and learned knowledge to develop regulatory solutions of  low complexity within established guidelines.  May collaborate with individuals at different levels in solving problems that are routine in nature. Interprets, executes, and recommends modifications to operating policies where appropriate.
• Acts as liaison with Terumo BCT International regulatory personnel and/or distributors to address questions and issues that arise as part of the registration and/or testing process.
• Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department.
• Assists in the assembly and creation of these documents for new product submissions to government agencies.
• Maintenance of moderately complex licenses/certificates, product approvals, and post market notifications.
• Prepares 510(k)s and/or international submissions as required.
• Coordinates responses to FDA or international agencies.
• Recommends strategies for earliest possible approvals/clearances for new product introductions in the US, Canada and EU.

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

Two (2) years experience in Regulatory Affairs, Clinical Affairs, Product Development or Quality Assurance or in another regulated environment. Or, an advanced degree with less than one year of experience in Regulatory Affairs or applicable area.

Skills

• Knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards
• Working knowledge of and ability to prepare regulatory documentation in compliance with regional regulatory requirements
• Familiarity with regulatory standards and demonstrates general knowledge with individual products/geographies
• Demonstarted ability to update sections of a regulatory submission under supervision
• Qualified within the Regulatory function with limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and and in writing.
• Demonstrate analytical and creative thinking skills and the ability to solve complex problems. 
• Able to identify adequacy of submission sections and overall content of submissions. Able to identify gaps and suggest solutions.
• Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities

Certificates, Licenses, Registrations

Quality Assurance or Regulatory Affairs Certification (RAC) desired.

LOCATION

Lakewood, Colorado or Remote.  

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.

Target Pay Range:  $76,400.00 to $95,500.00  -  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:  7.0%

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.