Manager, Regulatory Strategic Programs

Date: Oct 7, 2021

Location: Remote, NC, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 4870

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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

The Manager, Regulatory Strategic Programs will focus on the regulatory activities and deliverables to support the execution of strategic regulatory projects, including strategic manufacturing transfers, mergers, acquisitions, and divestitures. This role will be responsible for management of regulatory affairs activities related to the implementation of strategic programs which include a broad set of activities as described below.
This role is responsible for partnering with strategic manufacturing, corporate development, and business unit cross-functional teams to maintain a scalable, strategically appropriate and maintainable regulatory affairs group for executing on Strategic Programs and facilitating streamlined integrations. 
This role will provide direction and leadership to a team of regulatory professionals and will be responsible for influencing a wide range of functions and departments to drive the regulatory strategic programs while managing tactical activities and partnering effectively with a large and varied group of stakeholders.
 

Principal Responsibilities

•    Lead and develop the regulatory strategic programs team, creating and maintaining a functional RA team structure that can effectively and efficiently support the needs of the business 
•    Provide guidance and training on regulations, strategic regulatory planning, and regulatory support 
•    Management and development of staff.  Ensure that regulatory positions are staffed with qualified, motivated employees.  Ensure that reports are appropriately trained and have the resources necessary to do their assigned jobs.  Provide reports with career development opportunity and help them to realize their career goals
•    Provide direction and leadership with respect to regulatory strategy and execution for strategic programs
•    Facilitate communications with regulatory agencies, as needed
•    Align with Global RA leaders to ensure new or significantly changing worldwide regulatory requirements are evaluated and plans for compliance are incorporated into strategic program initiatives.
•    Communicate the changing global landscape of regulatory requirements as applicable to strategic program stakeholders
•    Collaborate with project team, business units, and workstream leads, as well as functional leaders from regulatory, quality and clinical functions to finance, R&D and operations to ensure efficient execution of a shared strategy
•    Ensure overall compliance; promote creative solutions; ensure on-time completion of individual tasks and project workstream goals
•    Communicate effectively with executive sponsors and steering committee members to ensure clear expectations, demonstrate progress and identify issues. Provide progress updates and regular reporting to business and functional leadership as required
 

Education / Experience Requirements

•    Bachelor’s degree in a business discipline or equivalent education/experience required
•    Minimum 2 years people management experience 
•    Minimum 5 years regulatory experience with demonstrated global knowledge
 

Specialized Skills / Other Requirements

•    Strong regulatory affairs experience, including excellent understanding of regulatory processes for registrations and modifications in a Global environment
•    Ability to lead, motivate, and empower team members while fostering strong internal team relationships
•    Influence management skills. Demonstrated ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals
•    Customer service/complaint handling and problem-solving skills
•    Computer literate (word processing, spreadsheets, databases)
•    Documentation skills, negotiating skills and the ability to communicate effectively
•    Research, logic and technical writing skills
•    Ability to support multiple projects and balance priorities, work independently or collaboratively to determine and develop solutions
•    Excellent verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization
•    Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas
 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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