IFU & Labeling Specialist
Teleflex

Job Info

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Expected Travel: None

Requisition ID:3356

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 Urology - NeoTract is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. As part of the Teleflex Interventional Urology business unit, NeoTract's focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function*1,2. The UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH in men over the age of 45. The UroLift System lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. More than 175,000 men have been treated with the UroLift System in select markets worldwide.** Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

*No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.

** Management estimate based on product sales and average units per procedure

1. Roehrborn, J Urology 2013 LIFT Study
2. McVary, J Sex Med 2014

Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.

Position Summary

The IFU & Labeling Specialist creates Instructions For Use (IFU) and product label content for the UroLift family of devices and will be an integral member of the Engineering Services team.

This position specializes in creation of content and artwork by collaborating with team members from regulatory affairs, quality assurance, packaging engineering, operations, marketing, medical affairs, legal, and product development. The ideal candidate is detail oriented, strong with collaboration and communication, proficient with software applications for designing and developing IFU and labeling content, and is able to efficiently navigate Quality System Processes (ECO for example) in the medical device field.

The position requires use of design software such as Adobe In-Design, Bartender, and/or other similar applications, and the ability to perform at high-levels in a fast-paced, dynamic environment.

Principal Responsibilities

• Supports the business unit by creating and/or updating IFUs and label artwork and specs to meet regulatory compliance and project goals.
• Works with cross functional team to define and write IFU and labeling content for new products or market expansion projects. Holds technical reviews of IFU drafts and labeling.
• Logs IFU and labeling changes to centrally document change history and rationale. Responsible for keeping IFU matrix current in QMS.
• Work with supply chain/purchasing to coordinate outsourced activities such as translation, printing, and delivery of printed labels to meet the needs of the projects.
• Efficiently executes ECOs, change assessments, gap assessments as needed for IFU/labeling release.
• Assists in creation of Unique Device Identification (UDI) as needed. Establishes and inputs device attributes into DSD. Submits publication requests.
• Validates internal label programs.
• Assists in systemic improvements to labeling program as requested.

• Performs other duties as assigned.
• Contributes to our culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun!

Education / Experience Requirements

• Bachelor's degree and a minimum of 2 years of applicable experience in a regulated industry
• Knowledge of International medical device labeling standards is preferred.
• Familiarity with document or content management systems concepts a plus.
• Experience using specialized applications such as Adobe In-Design, Bartender is preferred.

Specialized Skills / Other Requirements

• Detail oriented
• Ability to work independently and collaboratively as a team player.
• Strong technical writing skills
• Adaptable
• Basic understanding of compliance and regulatory requirements
• Ability to manage competing priorities
• Strong quality systems skills
• Excellent written and verbal communication and the ability communicate effectively with all levels of the organization.
• Self-motivated, organized, and proactive.
• Good documentation practices
• Ability to exhibit sound judgment in the formulation and solution of problems.
• Proficient computer skill including MS Office (Access, Word, and Excel)
• Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which NeoTract complies.

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.

© 2021Teleflex Incorporated. All rights reserved.

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