Regulatory Affairs Team Lead
Apply NowCompany: Teleflex
Location: Maple Grove, MN 55311
Description:
Expected Travel: Up to 25%
Requisition ID: 12025
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
Responsible for leading regulatory staff in support of product registrations, regulatory strategies, managing submissions and interactions with third parties and/or various regulatory agencies. The incumbent is also responsible for staying abreast of evolving regulatory requirements in the regions as they impact operational support.
Support Product Management and Regional RA groups in maintaining current worldwide regulatory registrations
Maintain the release of product distribution as part of product commercialization worldwide
Ensure regulatory requirements are met per quality management systems
Assess data from Regulatory Impact Assessments (RIA) and support regional RA to ensure global market authorization needs
Prioritize and manage projects independently based on corporate objectives.
Principal Responsibilities
Lead and manage day to day activities and regulatory staff
Support regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products globally
Partner with Regional RA teams for the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of submissions for new products, amendments of approved products and submissions that support the maintenance of existing licenses
Review and evaluate issues which may create regulatory or business obstacles and investigate solutions
Support the preparation of responses to regulatory agency questions and/or requests for information, as needed
Assist in regulatory due diligence processes, as needed
Support and participate in regulatory inspections, as needed
Support product recalls in collaboration with Product Management and Regional RA groups, as needed
Communicate regulatory activities and issues to key stakeholders, which may include Business Unit and Regional leadership
Apply understanding of the quality systems to job activities and projects
Train, develop, and mentor staff as appropriate
Assist with SAP Ship Control Table (SCT) maintenance activities and supporting Agile workflow. Execute SAP SCT transactions to release, hold or end product commercialization in coordination with Product Management and Regional RA as applicable
Assist with the maintenance of Market authorization information in appropriate spreadsheets/databases
Support tracking of Metrics
Provide inputs to Supply and Demand Planners as needed
Support Regulatory procedural consolidation/updates while maintaining QS compliance
Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards
Education / Experience Requirements
Bachelor's Degree in a relevant field
7+ years' experience in a highly regulated environment such as medical device, pharmaceutical, or other highly regulated environments
Minimum of 3 years regulatory affairs/compliance leadership experience
Specialized Skills / Other Requirements
Well-organized with attention to detail
Follows written and verbal instructions
Takes initiative; is a self-starter
Able to coordinate and prioritize activities
Basic database, Excel, Microsoft Word, SAP, and Agile skills
Good verbal and written communication skills
Efficiently proofreads technical documentation for consistency and formatting
Good intra- and interdepartmental collaboration skills
Identifies and solves basic problems
#LI-NR1
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
2025 Teleflex Incorporated. All rights reserved.
Requisition ID: 12025
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
Responsible for leading regulatory staff in support of product registrations, regulatory strategies, managing submissions and interactions with third parties and/or various regulatory agencies. The incumbent is also responsible for staying abreast of evolving regulatory requirements in the regions as they impact operational support.
Support Product Management and Regional RA groups in maintaining current worldwide regulatory registrations
Maintain the release of product distribution as part of product commercialization worldwide
Ensure regulatory requirements are met per quality management systems
Assess data from Regulatory Impact Assessments (RIA) and support regional RA to ensure global market authorization needs
Prioritize and manage projects independently based on corporate objectives.
Principal Responsibilities
Lead and manage day to day activities and regulatory staff
Support regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products globally
Partner with Regional RA teams for the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of submissions for new products, amendments of approved products and submissions that support the maintenance of existing licenses
Review and evaluate issues which may create regulatory or business obstacles and investigate solutions
Support the preparation of responses to regulatory agency questions and/or requests for information, as needed
Assist in regulatory due diligence processes, as needed
Support and participate in regulatory inspections, as needed
Support product recalls in collaboration with Product Management and Regional RA groups, as needed
Communicate regulatory activities and issues to key stakeholders, which may include Business Unit and Regional leadership
Apply understanding of the quality systems to job activities and projects
Train, develop, and mentor staff as appropriate
Assist with SAP Ship Control Table (SCT) maintenance activities and supporting Agile workflow. Execute SAP SCT transactions to release, hold or end product commercialization in coordination with Product Management and Regional RA as applicable
Assist with the maintenance of Market authorization information in appropriate spreadsheets/databases
Support tracking of Metrics
Provide inputs to Supply and Demand Planners as needed
Support Regulatory procedural consolidation/updates while maintaining QS compliance
Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards
Education / Experience Requirements
Bachelor's Degree in a relevant field
7+ years' experience in a highly regulated environment such as medical device, pharmaceutical, or other highly regulated environments
Minimum of 3 years regulatory affairs/compliance leadership experience
Specialized Skills / Other Requirements
Well-organized with attention to detail
Follows written and verbal instructions
Takes initiative; is a self-starter
Able to coordinate and prioritize activities
Basic database, Excel, Microsoft Word, SAP, and Agile skills
Good verbal and written communication skills
Efficiently proofreads technical documentation for consistency and formatting
Good intra- and interdepartmental collaboration skills
Identifies and solves basic problems
#LI-NR1
At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
2025 Teleflex Incorporated. All rights reserved.