Regulatory Affairs Specialist II

Date: Nov 27, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4608

 

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 Regulatory Affairs Specialist II is responsible for various regulatory affairs projects and assignments, which may include analyses, evaluations, preparation, and submission of documentation for regulatory submissions, registrations and product licenses. As an integral member of the Regulatory Affairs team, this position handles necessary regulatory activities required to support market entry and compliance of products, and helps ensure procedures comply with corporate and regulatory agency specifications. This position may support both domestic and international activities. Knowledge of regulations and standards including (but not limited to): EU MDD/MDR, FDA, CA-FDB, and ISO regulations/standards, is preferred, along with an ability to perform at high-levels in a fast-paced, high-growth dynamic environment.

Principal Responsibilities

•    Assists in deploying the Regulatory Program to ensure aggressive product approval and adoption within the framework of international regulations and standards including, but not limited to ISO13485; 21 CFR 803, 806, and 820; the current Canadian Medical Device Regulations (SOR/98-282); Medical Device Directive 93/42/EEC (and all applicable amendments); EU Medical Device Regulations (EU MDR) 2017/145; and MHLW Ordinance No 169, among others.
•    Create detailed project schedules, plans and timelines.
•    Proactively drive RA project deliverables with cross-functional and cross-business unit team members to support successful product submissions, registrations and reports.
•    Track project milestones and deliverables and provide regular status updates on completion and closure.
•    Perform regulatory assessments in support of new products or proposed product/process changes.
•    Perform complaint reportability analyses.
•    Generate, coordinate and handle regulatory submission documents for new products or changes to existing health authorities' filings.
•    Plan, write, submit, coordinate and support new product notifications, international registrations and other submissions as required.
•    Represent Regulatory Affairs and partner with various cross-functional teams throughout the organization (i.e. Marketing, Professional Education, Operations, R&D, Quality, including international cross-functional teams) on projects and other related tasks.
•    Partner with Clinical and Medical Affairs to support clinical deliverables and reports.
•    Partner with Quality and R&D to support regular product risk review activities as well as reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc.)
•    Conduct research of regulatory issues and information and dissemination of regulatory information to all levels of the organization.
•    Identify procedure and process enhancements for the continuous improvement of the Regulatory Affairs team.
•    Proactively drive activities to meet and/or exceed company objectives, milestone and timelines as they relate to regulatory activities.
•    Perform other related duties and responsibilities as assigned.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high- achieving, and fun!

Education / Experience Requirements

•    BS or BA degree, equivalent work experience, or related practical experience.
•    2-5 years of experience in regulatory affairs or equivalent; medical device experience is strongly preferred.
•    EU MDR experience is a plus.

Specialized Skills / Other Requirements

•    Ability to perform at a high level in a thriving environment.
•    Basic knowledge of regulations and standards, including FDA, CA-FDB, EU MDD/MDR, CMDR, MHLW, MFDS and ISO regulations/standards, for example ISO 10993 (requirements for biocompatibility).
•    RAC certification is a plus.
•    Ability to focus and achieve scheduled milestones, including contingency planning.
•    Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
•    Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed.
•    Proficiency in MS Office software programs.
•    Ability and willingness to travel up to 10% of the time.

 

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