Mar 05, 2019

Regulatory Affairs Specialist

  • Teleflex
  • Morrisville, NC, USA
Full time Pharmaceutical

Job Description

Date: Feb 19, 2019

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 310

 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.

Surgical - Whatever the latest surgical breakthrough looks like, Teleflex is working to make it happen. From our MiniLap® Percutaneous Surgical System to Weck® Hem-o-lok® Polymer Locking Ligation System, and Weck EFx® Shield™ Fascial Closure System, our portfolio of products adds up to a powerful offering of solutions that helps improve patient outcomes. These innovative, minimally invasive surgery products are offered alongside time-tested and trusted Pilling® Surgical Instrument and Lightsource solutions to provide a comprehensive set of solutions to meet the challenges of an evolving healthcare environment. 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 Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions, investigations, product development planning and regulatory agency interaction for the Surgical portfolio.

Principal Responsibilities 

  • Conduct appropriate research to develop strong regulatory strategies for new and modified products.
  • Assume full responsibility for global project submissions, including providing guidance, creating strategies, authoring submissions, and obtaining agency approvals.
  • Work with Quality, Operations, Engineering and other internal groups to investigate potential regulatory issues and to recommend solutions.
  • Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval and during audits to mitigate any potential risks.
  • Participate in the review and approval of Risk Management assessments.
  • Review and approve all Labeling (product, advertising and promotional) verbiage and evaluate for any regulatory impact.
  • Assist with departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
  • Monitor impact of evolving global regulations pertaining to submissions, practices, and procedures and communicate these regulations to internal stakeholders.
  • Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards. 

Education / Experience Requirements

  • Bachelor’s degree in a science or engineering field (or equivalent experience).
  • 1 to 3 years with regulatory medical device experience (preferably global experience including the US).
  • Should have some exposure to design control projects and regulatory submissions. 

Specialized Skills / Other Requirements

  • RAC certification is a plus.
  • Strong analytical and critical thinking skills.
  • Strong verbal and writing communication skills.
  • Strong organizational and time management stills.
  • Ability to manage multiple projects and meet deadlines.
  • Ability to comply with business and Regulatory Affairs ethical standards.
  • Proficient in MS Word, Excel, Power Point, and Outlook required.

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