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Regulatory Affairs, Senior Specialist (US Submissions)
| Terumo BCT, Inc.|
|life insurance, sick time, 401(k)|
United States, Colorado, Lakewood
|November 09, 2023|
Requisition ID: 30152
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.
As a Regulatory Affairs Specialist you play a pivotal role in ensuring regulatory compliance and driving the success of our innovative medical products. As a key contributor, you will develop strategic regulatory plans, expertly navigate submissions, and collaborate cross-functionally to address challenges and seize opportunities. Your in-depth knowledge of global medical device and pharmaceutical regulations, exceptional communication skills, and proven track record in achieving successful submissions will make you an invaluable asset. Be a part of our mission to make a lasting impact on healthcare while enjoying a work environment that encourages growth, creativity, and collaboration.
MINIMUM QUALIFICATION REQUIREMENTS
Certificates, Licenses, Registrations
Regulatory Affairs Certification (RAC) preferred.
An equivalent competency level acquired through a variation of these qualifications may be considered.
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).
Target Pay Range:$90,700.00to$113,300.00 -Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
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.
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 Technologiesin the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.