Sr. Regulatory Affairs Specialist

Date: Jul 20, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 4338

 

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.

 

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

Principal Responsibilities

•    Understand and apply regulations, standards, and guidance documents from US, EU and Canadian geographies
•    Prepare simple/intermediate/advanced regulatory strategies for new products and product line modifications/extensions
•    Prepare regulatory submissions including: Pre-submission requests, post-approval submissions (e.g., Annual Reports, Changes Being Effect, Prior Approval Supplements, 180-day Supplements, 30-day Notices etc.), 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 authorizations
•    Participate in product development through involvement in project team meetings, including risk assessment(s) as applicable
•    Review and approve test protocols and reports (DVT, biocompatibility, sterilization, packaging, shelf-life, etc.) to ensure they 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 changes for regulatory impact. Communicate impact to team and complete required documentation for decision.
•    Carry out assigned tasks, manage assignments, propose strategy.
•    Prioritize and manage projects independently based upon department and corporate objectives.
•    Research, prepare and present training to 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
 

Education / Experience Requirements

•    Bachelor’s Degree required
•    Five years of other relevant experience required. Ideal candidates will have experience authoring/reviewing / or approving regulatory applications, analytical test methods, justifications for specifications.

Specialized Skills / Other Requirements

•    Must be a well-organized self-starter that takes the initiative for indpendent work with attention to detail and has an ability to follow written & verbal instructions. 
•    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 Interventional 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: Boston