Regulatory Operations Associate

Date: Mar 25, 2024

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: None

Requisition ID: 10092

 

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 Regulatory Operations Associate will ensure the reliability and integrity of regulatory data used for compliance and documentation generation integrity by managing, tracking and analyzing regulatory data associated with regulated product submissions, market registrations, market access, and distribution controls. This role may also support process implementation activities in partnership with internal Global Regulatory teams.

Principal Responsibilities

Key responsibilities will include the following: 

•    Ensure regulatory compliance and data integrity within quality management and document control systems
•    Support system approvals for market registrations, regulatory distribution controls, and other key regulatory data, as required
•    Assist with implementation of regulatory data management, tracking and analysis in collaboration with multiple functional areas, sites and geographies/regions to provide regulatory intelligence
•    Develop an understanding of business processes related to product creation and market release
•    Support the ongoing management of regulatory data, develop reports, support metric and KPI development and compliance, participate in system and data audits 
•    Review Error reports and validations to correct data 
•    Perform pre and post load review and approvals
•    Support global Regulatory Affairs data management activities
•    Support global implementation of process improvements, efficiencies, or changes through collaboration across Global Regulatory Affairs
•    Participate in global regulatory data integrity projects, including development and implementation of innovative tools and solutions to meet regulatory and internal customer requirements as well as continuous process improvements
•    Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures, and housekeeping standards.  
 

Education / Experience Requirements

•    Bachelor’s degree in life sciences or technical discipline preferred
•    Minimum of 2 years relevant industry experience in regulated medical product data or system management
•    Background in regulatory affairs preferred
•    Affinity for information systems with preference for strong Agile and/or SAP skills
•    Skills that enable coordination of large volumes of data, including MS Suite, SharePoint, SmartSheets, etc.
•    Fluent in English, both written and spoken
 

Specialized Skills / Other Requirements

•    High attention to detail and accuracy – essential
•    Excellent interpersonal and team-oriented skills
•    Critical thinker with good communication skills
•    Flexibility, methodical and energetic with ability to manage multiple priorities
•    Ability to adapt to shifting priorities while adhering to rigorous timelines
•    Commitment to follow Teleflex Quality Systems and all processes and procedures 
•    Commitment to build professional work relationships 
•    Commitment to Core Values of People, Entrepreneurship, Building Trust and Make it Fun
•    Good organizational skills with cultural awareness and sensitivity
#LI-DR1

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: 877-880-8588 or Talent@Teleflex.com.

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.