Medical Affairs Program Manager

Teleflex Pleasanton , CA 94588

Posted 2 weeks ago

Date: Dec 29, 2020

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3189

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

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.
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Regulatory Affairs Analyst

Abbvie, Inc

Posted 5 days ago

VIEW JOBS 1/14/2021 12:00:00 AM 2021-04-14T00:00 About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. What Your New Manager Wants You To Know "I'm looking for a team player who is nimble and familiar with the fast-paced 510K product environment. If you want to jump start your path to a successful career and contribute to keeping patients safe and healthy, I would be very interested in receiving your resume. Let's discuss what you can bring to the team and what you aspire to do in the future" YOU ARE more than just a title, YOU ARE… * First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will * Assist in the development and deployment of the regulatory program that ensures aggressive product approval, adoption within the international standard ISO13485; 21 CFR 803, 806, and 820; the current Canadian Medical Device Regulations (SOR 980282); Medical Device Directive 93/42/EEC (and all applicable amendments); MHLW Ordinance No 169 and other applicable regulations and guidelines in accordance with corporate objectives. * Prepare regulatory submission documents for new products or changes to existing health authorities' filings. * Prepare new product notifications, CE Mark Technical Files/Dossiers, Investigational Device Exemptions and international regulatory submissions in various countries. * Partner with various teams throughout organization (Marketing, Promotions, Operations, R&D, Quality, etc.) on projects. * Assist with the management and execution process for global registrations and product life cycle management including generate product catalog and localization of labeling. * Mentoring junior team members. * Perform other related duties as assigned. #LI-PD1 Qualifications You Bring * BS or BA degree required, 1-2 years of experience in regulatory affairs. * Experience working in a medical device manufacturing company, preferably capital medical equipment manufacturer, preferred. * Knowledge of FDA and ISO regulations/standards. * Ability to focus on and achieve scheduled milestones. * Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed. * Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook. * The ability to travel, up to 10%. * Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, MDD, and all other international regulatory requirements with which AbbVie complies. In this role, we're looking for a leader who will: * Act as an Owner * Be Excellence Focused * Act as an Influencer Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Abbvie, Inc Pleasanton CA

Medical Affairs Program Manager