Regulatory Product Specialist

Date: Jan 10, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: None

Requisition ID: 5345

 

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.

 

US COVID-19 Vaccination Requirements

Teleflex is focused on the health and safety of our employees, their families, and our customers. Teleflex will comply with US government regulations regarding COVID-19 vaccination requirements for US workers. To ensure we are prepared for all applicable vaccination requirements, Teleflex is currently collecting vaccination status and accommodation requests from our US based employees.

Employees and new hires in sales or field-based roles that require vendor credentials to access medical facilities as an essential function of the job, may be required to obtain the COVID-19 vaccination based on customers/site requirement. This requirement is independent of Teleflex policy or any applicable US governmental regulations.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

•    Obtain timely  market authorizations for Teleflex Interventional products 
•    Ensure regulatory requirements are met for labeling and promotional materials
•    Assess the impact of proposed regulations and guidance documents on Teleflex‘s business
•    Train other departments on market authorization and related deliverable document reviews, regulations, and promotional and advertising topics 
 

Principal Responsibilities

•    Carry out assigned tasks, manage assignments, propose strategy
•    Manage tasks associated with assigned projects, set strategy
•    Prioritize and manage projects independently based upon department and corporate objectives
•    Develop and apply basic understanding of worldwide regulations, standards, and guidance documents
•    Understand and apply regulations, standards, and guidance documents from US, EU and Canadian geographies
•    Research, prepare and present training to Teleflex employees (peers and management) on Market Authorization trending, Promotion and Advertising, and other relevant regulatory topics with business impact
•    Identify regulatory compliance problems / recommend solutions
•    Prepare simple/intermediate/advanced regulatory strategies for new products and product line modifications/extensions
•    Participate in product development through involvement in project team meetings and CIA’s, including risk assessment
•    Analyze CIA’s and SCIA’s for regulatory impact. Communicate impact to team and complete required documentation for decision
•    Review and approve test protocols and reports (DVT, biocompatibility, sterilization, packaging, shelf-life, etc.) that will meet regulatory requirements 
•    Assist in the development, review and approval of product labels, instructions for use, and promotional materials to ensure regulatory requirements are met
•    Analyze product changes for impact to current regulatory filing. Communicate impact to team and complete required documentation for decision
•    Prepare regulatory submissions including: Regulatory File Memos, 510(k)s, technical files/design dossier to support self-authorizations and Notices of Changes, Canadian license amendments or applications,  essential requirements checklists and work with regulatory agencies to obtain market authorization.
 

Education / Experience Requirements

•    Bachelor’s Degree required
•    Three years of other relevant experience required
 

Specialized Skills / Other Requirements

•    Must be a well-organized self-starter with attention to detail, and ability to follow written & verbal instructions, take initiative, 
•    manage assigned projects and related activities, propose market authorization strategies, effectively participate on cross-functional teams and identify and solve intermediate level problems. 
•    Must possess a basic understanding of product risk/benefit concepts, working knowledge of US & International regulations applicable to market authorization for Teleflex products, good verbal communication, technical writing, intra- & interdepartmental communication and collaboration skills.
 

 

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.


Nearest Major Market: Minneapolis