Regulatory Affairs Specialist at TerumoBCT, Inc.
Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Lakewood, Colorado
State: Colorado (US-CO)
JOB TITLE: Regulatory Affairs Specialist
Working without significant direction, assists in fulfilling Regulatory compliance requirements by applying a thorough understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices, pharmaceuticals, or biologics.
* Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas
* Identifies and defines contents for Regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
* Maintenance of sometimes complex existing licenses/certificates, product approvals and simple post market notifications
* Responsible for overall compliance with Regulatory requirements that apply to the product development cycle. Makes recommendations on how to achieve compliance.
* Works with manufacturing, engineering, and other functional groups on Regulatory compliance issues
* Applies standard procedure and learned knowledge to develop regulatory solutions of moderate to low complexity within established guidelines. May collaborate with individuals at different levels in solving problems that are routine in natureInterprets, executes, and recommends modifications to operating policies where appropriate
* The effect of Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department
MINIMUM QUALIFICATION REQUIREMENTS
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.
Minimum 5 years experience in Regulatory Affairs.
* In depth 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 author sections of a regulatory submission under supervision, with content review at end
* Qualified within the Regulatory function with limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function
* Recognize and awareness of gaps and potentially suggest solutionsAble to identify adequacy of sections and overall content of submissions
* 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
* Must be highly skilled in timely and accurate decisionsDemonstrated analytical and creative thinking skills and the ability to solve complex problems
Certificates, Licenses, Registrations
Regulatory Affairs Certification (RAC) desired
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.
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, 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.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.
Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
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.
Our company has almost $1B in annual revenues and has been voted and recognized as:
* Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
* Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
* One of Colorado s Healthiest Employers by Denver Business Journal (2014 & 2015)
* Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015
Our award-winning culture embraces:
* Leading technology through innovation and R&D
* Wellness programs
* Commitment to quality
* An environment that values, respects and rewards your individual contributions
* A philosophy of intentional growth and responsiveness to world health issues
Click Here to see what our associates have to say about our culture.
Each associate has a positive impact on our future by:
* Connecting to the lives of the patients we ultimately serve
* Growing through professional and leadership development activities
* Sharing company success through incentive plans
If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.