Terumo BCT, Inc.
Manager, Regulatory Affairs
Terumo BCT, Inc., Lakewood, Colorado, United States,
Requisition ID:
32768
At 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 seeking an experienced Regulatory Affairs Manager to lead our efforts in managing and overseeing regulatory submissions and product registrations across medical devices, pharmaceuticals, and biologics. This key role involves ensuring compliance with global regulatory standards, supporting new product launches, and collaborating with cross-functional teams to prepare and submit documentation to health authorities.
ESSENTIAL DUTIES
Provide direction, leadership, and coaching to RA Associates to meet schedules and resolve technical or operational problems.
Lead the development of strategic input and provide technical guidance on regulatory requirements for new technologies and product modifications.
Manage Associates in the development of regulatory strategies.
Responsible for preparation or review of regulatory submissions.
Represent regulatory on teams to develop regulatory strategies.
Manage multiple projects and prioritize tasks on a day-to-day basis to meet project schedules.
Identify the need for new or modified regulatory procedures and lead in their development and implementation.
Represent specific business areas or geographies as the primary contact with internal colleagues and regulatory authorities.
Maintain and grow regulatory knowledge of domestic and international regulations.
Negotiate and interact with regulatory authorities during the development and review process.
Communicate regulatory strategy effectively to applicable departments and regulatory agencies.
Review advertising and promotional materials for compliance with global regulations.
Act as an effective regulatory consultant to management and other functions.
Act as a leader who embodies regulatory expertise as well as business acumen.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent education and experience.
Experience
8 years experience in Regulatory Affairs and 1 year of direct or indirect management experience preferred.
Direct experience in gaining FDA or Notified Body approvals for devices, drugs, or biologics.
Skills
Excellent written and verbal communication skills.
Self-motivated with the ability to take ownership of responsibilities.
Prioritization and multitasking skills.
Leadership and mentoring skills.
Confidentiality in dealing with regulatory documentation.
In-depth knowledge of U.S. and/or international medical device and/or pharmaceuticals regulations.
Ability to understand how product approval strategy interacts with business strategy.
Demonstrated ability to collaborate and think innovatively.
Ability to manage ambiguity and resolve regulatory issues.
Results-oriented and decisive.
Detail-oriented and organized.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
Certificates, Licenses, Registrations
Regulatory Affairs Certification (RAC) preferred.
LOCATION
Lakewood, Colorado - Open to candidates willing to relocate.
TRAVEL
Some travel may be required (5-10%).
PHYSICAL REQUIREMENTS
Typical 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 essential duties.
Target Pay Range:
$125,900.00 to $157,400.00 - Salary to be determined by various factors.
At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, and recognition programs.
We are proud to be an Equal Opportunity Affirmative Action Employer.
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32768
At 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 seeking an experienced Regulatory Affairs Manager to lead our efforts in managing and overseeing regulatory submissions and product registrations across medical devices, pharmaceuticals, and biologics. This key role involves ensuring compliance with global regulatory standards, supporting new product launches, and collaborating with cross-functional teams to prepare and submit documentation to health authorities.
ESSENTIAL DUTIES
Provide direction, leadership, and coaching to RA Associates to meet schedules and resolve technical or operational problems.
Lead the development of strategic input and provide technical guidance on regulatory requirements for new technologies and product modifications.
Manage Associates in the development of regulatory strategies.
Responsible for preparation or review of regulatory submissions.
Represent regulatory on teams to develop regulatory strategies.
Manage multiple projects and prioritize tasks on a day-to-day basis to meet project schedules.
Identify the need for new or modified regulatory procedures and lead in their development and implementation.
Represent specific business areas or geographies as the primary contact with internal colleagues and regulatory authorities.
Maintain and grow regulatory knowledge of domestic and international regulations.
Negotiate and interact with regulatory authorities during the development and review process.
Communicate regulatory strategy effectively to applicable departments and regulatory agencies.
Review advertising and promotional materials for compliance with global regulations.
Act as an effective regulatory consultant to management and other functions.
Act as a leader who embodies regulatory expertise as well as business acumen.
MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent education and experience.
Experience
8 years experience in Regulatory Affairs and 1 year of direct or indirect management experience preferred.
Direct experience in gaining FDA or Notified Body approvals for devices, drugs, or biologics.
Skills
Excellent written and verbal communication skills.
Self-motivated with the ability to take ownership of responsibilities.
Prioritization and multitasking skills.
Leadership and mentoring skills.
Confidentiality in dealing with regulatory documentation.
In-depth knowledge of U.S. and/or international medical device and/or pharmaceuticals regulations.
Ability to understand how product approval strategy interacts with business strategy.
Demonstrated ability to collaborate and think innovatively.
Ability to manage ambiguity and resolve regulatory issues.
Results-oriented and decisive.
Detail-oriented and organized.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
Certificates, Licenses, Registrations
Regulatory Affairs Certification (RAC) preferred.
LOCATION
Lakewood, Colorado - Open to candidates willing to relocate.
TRAVEL
Some travel may be required (5-10%).
PHYSICAL REQUIREMENTS
Typical 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 essential duties.
Target Pay Range:
$125,900.00 to $157,400.00 - Salary to be determined by various factors.
At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, and recognition programs.
We are proud to be an Equal Opportunity Affirmative Action Employer.
#J-18808-Ljbffr