Regulatory Affairs Liaison

Date: Sep 19, 2021

Location: Remote, NC, US

Company: Teleflex

Expected Travel: None

Requisition ID: 4146

 

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

Under the guidance of the RAQA Leader: Strategic Manufacturing, support the Strategic Manufacturing group to coordinate completion of global submissions and registration documents in support of manufacturing transfer projects and track their progress against planned timelines. The candidate is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain worldwide Regulatory clearances/approvals.

Principal Responsibilities

•    Clearly communicate regulatory requirements for the strategic manufacturing projects to the project managers and program manager. 
•    Participate in project meetings to ensure that the teams remain compliant with regulatory requirements during the planning, execution and closure of the projects.
•    Assist in producing new or revised global medical device submissions in the format consistent with the governing SOP’s.
•    Liaise with Business Unit Regulatory Affairs functions to track and monitor regulatory submission timelines, facilitate recurring meetings, and provide meeting minutes.
•    Manage regulatory specific project deliverables and interdependencies; communicate risks or delays in a timely manner.
•    Interface with various departments to collect and organize required documentation materials.
•    Keep abreast of relevant domestic, European, and other international regulatory requirements for medical devices.
•    Provide other department support as required by immediate supervisor.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.   
 

Education / Experience Requirements

•    4 year college degree; preferably in a scientific discipline such as biology, microbiology, chemistry, engineering or medical technology.
•    Minimum 2 years’ experience working in an FDA or ISO regulated environment.
•    1 – 2 years office administration or project management
 

Specialized Skills / Other Requirements

•    Well-organized with excellent verbal and written communication skills.
•    Proficient at monitoring multiple activities simultaneously with attention to detail and ability to prioritize appropriately.
•    Knowledge of electronic document management systems and computer office applications.
•    Preferred: understanding of domestic and international medical device regulations.
•    Preferred: experience working with remote teams
 

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.

© 2021 Teleflex Incorporated. All rights reserved.