TERUMO BCT, INC
Principal, Regulatory Affairs Specialist
TERUMO BCT, INC, Lakewood, Colorado, United States,
Principal, Regulatory Affairs Specialist
Date:
Aug 5, 2024Location:
Lakewood, CO, USRequisition ID:
32476At Terumo Blood and Cell Technologies, our 7,000+ global associates are 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.We are actively seeking a highly skilled Principal Regulatory Affairs Specialist to lead our FDA, Health Canada, and/or EU MDR submissions process. As a key player in our organization, you will leverage your extensive expertise to navigate the regulatory landscape, ensuring successful approvals for our innovative healthcare solutions. Your responsibilities will include developing and executing regulatory strategies, collaborating with cross-functional teams, and ensuring compliance with global regulations.ESSENTIAL DUTIESRecognized as an expert within the company with diverse understanding and experience working with multiple functions.Responsible for managing the complete lifecycle of multiple complex products and/or projects simultaneously.Acts as a company representative, creating and maintaining positive relationships with regulatory agencies throughout the development process.Develops solutions to problems of high complexity that may affect diverse functional areas of the business.Identifies problems and significantly improves existing methods and techniques.Maintains proficiency in worldwide regulatory requirements; monitors changes in the regulatory landscape and communicates these changes to the organization.Represents specific business areas as the primary contact; interacts with management teams and regulatory authorities.May review device labeling, advertising materials, and product manufacturing changes for compliance with global regulations.Can interpret and recommend modifications to operating policies within the function.Reviews staff submissions to identify adequacy of sections and overall content.Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and cross-functional teams.Acts as a leader who embodies regulatory expertise as well as business acumen.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor’s degree in physical/biological sciences or engineering preferred, or equivalent education and experience may be considered.ExperienceMinimum 10 years experience in Regulatory Affairs.Clinical or statistical experience desired.SkillsExpert knowledge related to Regulatory issues involving multiple product lines or geographies.Demonstrated success in the management of regulatory submissions such as CE Mark for Class II-III products, IDE’s, IND’s, 510(k)’s, NDA’s, ANDA’s.Advanced expertise with medical device regulations such as CFR 820, ISO 13485, ISO 62304, ISO 60601-1.Ability to comprehend principles of engineering, software development, chemistry, and science.Nimble learning and ability to actively seek out relevant legislation and competitive information.Resourcefulness and ability to drive for results on new, high challenge products.Results oriented and decisive.Demonstrated analytical and creative thinking skills.Experience in negotiation, listening, persuasion, collaboration, and analytic based judgment.Knowledge and use of relevant PC software applications.Demonstrated ability to communicate effectively both verbally and in writing.-Or-An equivalent competency level acquired through a variation of these qualifications may be considered.Certificates, Licenses, RegistrationsLOCATIONTRAVELSome travel required (up to 5%)PHYSICAL REQUIREMENTSTypical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.Target Pay Range:
$121,200.00 to $151,600.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant.Target Bonus on Base:
10.0%At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, and well-being programs.Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination.Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.
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Date:
Aug 5, 2024Location:
Lakewood, CO, USRequisition ID:
32476At Terumo Blood and Cell Technologies, our 7,000+ global associates are 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.We are actively seeking a highly skilled Principal Regulatory Affairs Specialist to lead our FDA, Health Canada, and/or EU MDR submissions process. As a key player in our organization, you will leverage your extensive expertise to navigate the regulatory landscape, ensuring successful approvals for our innovative healthcare solutions. Your responsibilities will include developing and executing regulatory strategies, collaborating with cross-functional teams, and ensuring compliance with global regulations.ESSENTIAL DUTIESRecognized as an expert within the company with diverse understanding and experience working with multiple functions.Responsible for managing the complete lifecycle of multiple complex products and/or projects simultaneously.Acts as a company representative, creating and maintaining positive relationships with regulatory agencies throughout the development process.Develops solutions to problems of high complexity that may affect diverse functional areas of the business.Identifies problems and significantly improves existing methods and techniques.Maintains proficiency in worldwide regulatory requirements; monitors changes in the regulatory landscape and communicates these changes to the organization.Represents specific business areas as the primary contact; interacts with management teams and regulatory authorities.May review device labeling, advertising materials, and product manufacturing changes for compliance with global regulations.Can interpret and recommend modifications to operating policies within the function.Reviews staff submissions to identify adequacy of sections and overall content.Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and cross-functional teams.Acts as a leader who embodies regulatory expertise as well as business acumen.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor’s degree in physical/biological sciences or engineering preferred, or equivalent education and experience may be considered.ExperienceMinimum 10 years experience in Regulatory Affairs.Clinical or statistical experience desired.SkillsExpert knowledge related to Regulatory issues involving multiple product lines or geographies.Demonstrated success in the management of regulatory submissions such as CE Mark for Class II-III products, IDE’s, IND’s, 510(k)’s, NDA’s, ANDA’s.Advanced expertise with medical device regulations such as CFR 820, ISO 13485, ISO 62304, ISO 60601-1.Ability to comprehend principles of engineering, software development, chemistry, and science.Nimble learning and ability to actively seek out relevant legislation and competitive information.Resourcefulness and ability to drive for results on new, high challenge products.Results oriented and decisive.Demonstrated analytical and creative thinking skills.Experience in negotiation, listening, persuasion, collaboration, and analytic based judgment.Knowledge and use of relevant PC software applications.Demonstrated ability to communicate effectively both verbally and in writing.-Or-An equivalent competency level acquired through a variation of these qualifications may be considered.Certificates, Licenses, RegistrationsLOCATIONTRAVELSome travel required (up to 5%)PHYSICAL REQUIREMENTSTypical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.Target Pay Range:
$121,200.00 to $151,600.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant.Target Bonus on Base:
10.0%At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, and well-being programs.Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination.Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.
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