Director, Regulatory Affairs (Remote)

Date: Sep 28, 2022

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 6987

 

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 Director, Regulatory Affairs is responsible for overseeing all Interventional Urology (IU) regulatory activities and providing regulatory guidance and leadership to the business unit. The successful candidate will have a strong background in US and International Regulatory Affairs and can effectively lead individuals, teams, and projects in a high-paced dynamic environment.  Primary responsibilities include:

  • Directing regulatory affairs department personnel to ensure that products are legally registered in the applicable countries prior to distribution.
  • Creation, approval, and maintenance of global submission and registration documentation and records.
  • Ensuring compliance to all relevant US and international regulations/laws as relevant to regulatory affairs and IU products, including labeling and promotional materials.
  • Obtaining and maintaining US and international market authorizations/approvals for Interventional Urology (IU) products.
  • Informing IU Leadership of the regulatory status of products, significant regulatory issues, and emerging regulatory requirements that may impact IU products or processes.
  • Serving as the Person Responsible for Regulatory Compliance (PRRC), as appointed, for the business unit as applicable.
     

Principal Responsibilities

•    Develop and implement strategies and timelines for worldwide regulatory market authorizations in partnership with regional Teleflex affiliates.
•    Observe and anticipate trends in market authorizations and related reviews by regulatory bodies and ensures templates and internal guidelines are maintained to current standards. 
•    Oversee the preparation of regulatory submissions for the US (including 510(k)s, IDEs, PMAs) and international markets (including technical files/documentation, design dossier, license amendments/applications, and new market authorizations).  
•    Work with Clinical and Medical Affairs to develop and execute clinical research studies to support market authorizations or promotional materials.
•    Represent IU Regulatory interests and participate in FDA, Notified Body, or other inspections/audits as necessary.
•    Ensure compliance with worldwide regulatory requirements for IU products and promotion/advertising. 
•    Anticipate and address regulatory challenges, obstacles, and emerging issues throughout the product lifecycle.
•    Provide input to stakeholders on current and new regulatory requirements.
•    Contribute to annual product development plans and strategies, including product pipeline and M&A activities.
•    Represent the company professionally, lead and/or facilitate communications with external agencies and internal teams.
•    Supervise and mentor staff and ensure duties, responsibilities, goals/objectives, expectations and authority for direct reports are defined and understood.
•    Ensure staff is adequately trained, skilled, and motivated to perform their responsibilities effectively, proficiently, and of the highest quality.
•    Maintain and ensure all governing policies, procedures, work instructions, etc. are followed and up to date with current requirements.
•    Conduct regulatory reporting assessments, prepare adverse event reports, and lead Field Safety Corrective Activities as necessary.
•    Monitor, analyze and advise on existing and emerging regulatory trends and requirements and provide input for Management Reviews.
 

Education / Experience Requirements

•    Bachelor's Degree in business or a technical, engineering, or science discipline required or equivalent experience.
•    Minimum 10 years progressive experience in relevant regulatory roles with FDA Class II & III medical devices, minimum 3 years international regulatory experience,  minimum 5 years managing direct reports.
 

Specialized Skills / Other Requirements

•    Ability to plan, direct, and perform regulatory and quality work in the medical device industry.
•    Strong project management, and written and oral communication skills.
•    Ability to identify and lead projects from conception to completion; understanding of budget and planning process and implementation. 
•    In-depth working knowledge of FDA, EU, and other relevant international regulatory agency guidelines, policies, standards, processes/practices, requirements, and precedents relevant to IU products.
•    Strong interpersonal skills, strong cross-functional teamwork, self-motivated, and reliable. 
•    Must be able to work effectively with all levels of the organization.
 

 

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: San Francisco
Nearest Secondary Market: Oakland