Terumo
Principal, Regulatory Affairs Specialist
Terumo, Lakewood, Colorado, United States,
Principal, Regulatory Affairs Specialist
Date:
Sep 3, 2024
Location:
Lakewood, CO, US
Company:
Terumo BCT, Inc.
Requisition ID:
32476
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.
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 DUTIES
Recognized as an expert within the company with diverse and varied understanding and experience working with multiple functions that are unrelated.
Responsible for managing 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 (Pre-Submissions, Submissions, Post Market).
Develops, or is responsible for the development of, solutions to problems of high complexity that may affect diverse functional areas of the business or company or unusual complexity in the function.
Identify problems and significantly improve, change or adapt existing methods and techniques; may be involved in creating/proposing strategy.
Maintains proficiency in worldwide regulatory requirements; monitors changes in the regulatory landscape and is responsible to communicate these changes and the impact to the organization.
Represent specific business areas or geographies as the primary contact; interacts with business area management teams and/or regulatory authorities.
May review device labeling, advertising materials and product manufacturing changes for compliance with global regulations; analyzes and recommends appropriate changes.
Can interpret and recommend modifications to operating policies within the function, which may influence overall objectives and long-range goals.
Reviews staff submissions to identify adequacy of sections, overall content of submissions and completeness of submission and consistency of story.
Responsible for authoring entire submissions/dossiers.
Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross-functional teams.
Acts as a leader who embodies regulatory expertise as well as business acumen with a positive corporate mindset.
MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor’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. Such as a Masters in Regulatory Affairs or MBA.
ExperienceMinimum 10 years experience in Regulatory Affairs.
Clinical or statistical experience desired.
PMA experience a plus.
Skills
Possess expert knowledge related to Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures.
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; however, expertise knowledge in pharmaceutical or biologic regulations and standards would be considered.
Ability to comprehend principles of engineering, software development, chemistry, and science in order to work closely with a variety of associates to better understand the products and support the product lifecycle.
Nimble learning and ability to actively seek out relevant legislation and competitive information on product lines.
Resourcefulness and ability to drive for results to work on new, high challenge products, new platforms or projects across business areas.
Must be results oriented and decisive. Failure to obtain results or arrive at appropriate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.
Demonstrated analytical and creative thinking skills and the ability to solve complex problems.
Experience in an environment where skills in negotiation, listening, persuasion, collaboration, compromise and analytic-based judgement is used daily.
Knowledge and use of relevant PC software applications and skills to use them effectively.
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, RegistrationsRegulatory Affairs Certification (RAC) desired.
LOCATIONRemote or Lakewood, Colorado.
TRAVELSome travel required (up to 5%)
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:
$121,200.00 to $151,600.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market dataTarget Bonus on Base:
10.0%
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.
We are proud to be an Equal Opportunity Affirmative Action Employer.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.
#J-18808-Ljbffr
Date:
Sep 3, 2024
Location:
Lakewood, CO, US
Company:
Terumo BCT, Inc.
Requisition ID:
32476
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.
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 DUTIES
Recognized as an expert within the company with diverse and varied understanding and experience working with multiple functions that are unrelated.
Responsible for managing 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 (Pre-Submissions, Submissions, Post Market).
Develops, or is responsible for the development of, solutions to problems of high complexity that may affect diverse functional areas of the business or company or unusual complexity in the function.
Identify problems and significantly improve, change or adapt existing methods and techniques; may be involved in creating/proposing strategy.
Maintains proficiency in worldwide regulatory requirements; monitors changes in the regulatory landscape and is responsible to communicate these changes and the impact to the organization.
Represent specific business areas or geographies as the primary contact; interacts with business area management teams and/or regulatory authorities.
May review device labeling, advertising materials and product manufacturing changes for compliance with global regulations; analyzes and recommends appropriate changes.
Can interpret and recommend modifications to operating policies within the function, which may influence overall objectives and long-range goals.
Reviews staff submissions to identify adequacy of sections, overall content of submissions and completeness of submission and consistency of story.
Responsible for authoring entire submissions/dossiers.
Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross-functional teams.
Acts as a leader who embodies regulatory expertise as well as business acumen with a positive corporate mindset.
MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor’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. Such as a Masters in Regulatory Affairs or MBA.
ExperienceMinimum 10 years experience in Regulatory Affairs.
Clinical or statistical experience desired.
PMA experience a plus.
Skills
Possess expert knowledge related to Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures.
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; however, expertise knowledge in pharmaceutical or biologic regulations and standards would be considered.
Ability to comprehend principles of engineering, software development, chemistry, and science in order to work closely with a variety of associates to better understand the products and support the product lifecycle.
Nimble learning and ability to actively seek out relevant legislation and competitive information on product lines.
Resourcefulness and ability to drive for results to work on new, high challenge products, new platforms or projects across business areas.
Must be results oriented and decisive. Failure to obtain results or arrive at appropriate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.
Demonstrated analytical and creative thinking skills and the ability to solve complex problems.
Experience in an environment where skills in negotiation, listening, persuasion, collaboration, compromise and analytic-based judgement is used daily.
Knowledge and use of relevant PC software applications and skills to use them effectively.
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, RegistrationsRegulatory Affairs Certification (RAC) desired.
LOCATIONRemote or Lakewood, Colorado.
TRAVELSome travel required (up to 5%)
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:
$121,200.00 to $151,600.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market dataTarget Bonus on Base:
10.0%
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.
We are proud to be an Equal Opportunity Affirmative Action Employer.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.
#J-18808-Ljbffr