Terumo
Senior Regulatory Affairs Specialist
Terumo, Lakewood, Colorado, United States,
Senior Regulatory Affairs Specialist
Date:
Sep 3, 2024
Location:
Lakewood, CO, US
Company:
Terumo BCT, Inc.
Requisition ID:
32482
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.
As a Senior Regulatory Affairs Specialist, you play a pivotal role in ensuring regulatory compliance and driving the success of our innovative medical products. You will develop strategic regulatory plans, 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.
Essential Duties
Develop regulatory strategies and plans for new or modified products.
Identify and define contents for regulatory submissions/dossiers. Supervise the assembly of the regulatory submissions.
Write and prepare U.S. and international submissions for new products ensuring timely approval for market release.
Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations.
Maintain and grow regulatory knowledge of domestic and international regulations, guidelines, and standards.
Represent regulatory on project teams to develop regulatory strategies.
Review product labeling for compliance with applicable US and international regulations.
Negotiate and interact with Regulatory Agencies and Certification authorities to ensure submission approval.
Prepare and conduct regulatory related training for the business.
Review advertising and promotional materials for compliance with global regulations.
Collaborate with individuals at different levels to develop solutions to problems.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle.
Participate in preparation and execution of audits required to maintain market access.
Identify the need for new or modified regulatory procedures and participate in development and implementation.
Provide mentoring, training, and support to other members of the regulatory department.
Assist in regulatory due diligence for potential and new acquisitions.
Minimum Qualification RequirementsEducation
Bachelor’s degree in physical/biological sciences or engineering preferred.
Previous relevant experience and/or combined with a Masters in Regulatory Affairs may also be considered.
Experience
Seven (7) years' experience in Regulatory Affairs preferred or a mix of Regulatory and Quality experience in a regulated environment.
Skills
Excellent written and verbal communication skills.
Self-motivated and able to take ownership of responsibilities.
Ability to prioritize and handle several projects concurrently.
Leadership and mentoring skills.
Confidentiality in dealing with regulatory and clinical documentation.
Experience authoring a regulatory submission in the US, EU and/or Canada.
In-depth working knowledge of U.S. and/or international medical device and/or pharmaceuticals regulations.
Ability to apply business insight to product approval strategy.
Demonstrated ability to collaborate and think innovatively.
Nimble learning and ability to seek out relevant legislation and competitive information.
Certificates, Licenses, RegistrationsRegulatory Affairs Certification (RAC) preferred.
LocationRemote or Lakewood, Colorado.
TravelSome travel required (up to once a quarter).
Physical Requirements
Typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
Target Pay Range:
$95,900.00 to $119,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant.
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.
#J-18808-Ljbffr
Date:
Sep 3, 2024
Location:
Lakewood, CO, US
Company:
Terumo BCT, Inc.
Requisition ID:
32482
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.
As a Senior Regulatory Affairs Specialist, you play a pivotal role in ensuring regulatory compliance and driving the success of our innovative medical products. You will develop strategic regulatory plans, 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.
Essential Duties
Develop regulatory strategies and plans for new or modified products.
Identify and define contents for regulatory submissions/dossiers. Supervise the assembly of the regulatory submissions.
Write and prepare U.S. and international submissions for new products ensuring timely approval for market release.
Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations.
Maintain and grow regulatory knowledge of domestic and international regulations, guidelines, and standards.
Represent regulatory on project teams to develop regulatory strategies.
Review product labeling for compliance with applicable US and international regulations.
Negotiate and interact with Regulatory Agencies and Certification authorities to ensure submission approval.
Prepare and conduct regulatory related training for the business.
Review advertising and promotional materials for compliance with global regulations.
Collaborate with individuals at different levels to develop solutions to problems.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle.
Participate in preparation and execution of audits required to maintain market access.
Identify the need for new or modified regulatory procedures and participate in development and implementation.
Provide mentoring, training, and support to other members of the regulatory department.
Assist in regulatory due diligence for potential and new acquisitions.
Minimum Qualification RequirementsEducation
Bachelor’s degree in physical/biological sciences or engineering preferred.
Previous relevant experience and/or combined with a Masters in Regulatory Affairs may also be considered.
Experience
Seven (7) years' experience in Regulatory Affairs preferred or a mix of Regulatory and Quality experience in a regulated environment.
Skills
Excellent written and verbal communication skills.
Self-motivated and able to take ownership of responsibilities.
Ability to prioritize and handle several projects concurrently.
Leadership and mentoring skills.
Confidentiality in dealing with regulatory and clinical documentation.
Experience authoring a regulatory submission in the US, EU and/or Canada.
In-depth working knowledge of U.S. and/or international medical device and/or pharmaceuticals regulations.
Ability to apply business insight to product approval strategy.
Demonstrated ability to collaborate and think innovatively.
Nimble learning and ability to seek out relevant legislation and competitive information.
Certificates, Licenses, RegistrationsRegulatory Affairs Certification (RAC) preferred.
LocationRemote or Lakewood, Colorado.
TravelSome travel required (up to once a quarter).
Physical Requirements
Typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
Target Pay Range:
$95,900.00 to $119,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant.
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.
#J-18808-Ljbffr