DHR Reviewer

Teleflex Exton , PA 19341

Posted 2 months ago

Date: Apr 15, 2020

Location: Exton, PA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 2426

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 - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, AC3 Optimus Intra-Aortic Balloon Pump and OnControl Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

Built on a history of innovation, our Arrow brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular-related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices for intraosseous vascular access and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

This position performs review of device history record documentation for incoming components, sub-assemblies, and finished devices.

Principal Responsibilities

  • Reviews incoming inspections forms for completeness and accuracy

  • Review sub-assembly and finished devices device history records (DHRs) prior to closure for completeness, accuracy, and compliance with specifications per applicable procedures

  • Maintains a record of DHR errors to elevate to supervisor for nonconformance generation if applicable

  • Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release

  • Coordinates with manufacturing department to ensure timely release of product

  • Assist in lot release activities when required

  • Support QC inspectors as backup when required

  • Perform related duties and responsibilities as required

Education / Experience Requirements

  • Associates degree strongly preferred

  • Two years of relevant QA/QC inspection experience

  • Experience in medical industry is preferred

  • Previous Cleanroom experience with GDP, GMP and regulatory

Specialized Skills / Other Requirements

  • Able to work in a high-performing team environment and possess a demonstrated ability to multi-task and accommodate changing priorities within compressed timelines

  • Superior verbal and presentation skills required

  • Requires familiarity with computers, Microsoft Office software, keyboarding, email and internet

  • Previous Quality Management System experience in an FDA regulated environment

  • Working knowledge of Medical Device industry a plus

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, Rsch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.


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
lc_ad

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
Medical Information And Review Manager

Takeda Pharmaceutical Company Ltd

Posted 1 week ago

VIEW JOBS 5/27/2020 12:00:00 AM 2020-08-25T00:00 By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that I agree with Takeda's Privacy Notice, Privacy Policy and Terms of Use. Job Description Title: Medical Information and Review Manager Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Information and Review Manager in our Lexington, MA or Exton, PA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. As a Medical Information and Review Manager, you will be empowered and will contribute to Takeda's mission. A typical day will include: POSITION OBJECTIVES: * Deliver high-quality, balanced and timely medical and scientific information regarding specific products, upon the request of internal and external business partners, health care professionals (HCPs) and consumers. * Manage Medical Information activities for specific products to include development of standard written and verbal responses, including Clinical Dossiers, Letters and Frequently Asked Questions (FAQs), and periodic review of inquiries and responses. * Provide medical information / clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand teams) and external stakeholders such as healthcare professionals, patients and advocacy groups. * Provide medical and scientific review of: promotional materials, press releases, and sales training communications to support the promotional review process, medical and scientific slides housed in the Medical Affairs slide repository, and other pertinent publications in the therapeutic areas as needed. POSITION ACCOUNTABILITIES: * Develop, maintain, and provide high quality medical and scientific information, including Standard and Custom Response Letters, Clinical Dossiers, and FAQs to both internal and external customers. * Grant formal approval via signature authority for the cross-functional promotional review activities including: 1) providing strategic scientific consults on brand messages, 2) reviewing promotional materials for content and accuracy, 3) coordinate the development and review and approval of clinical data on file to support promotional claims. * Formulate medical responses and recommendations (including errata) as requested by scientific journals and organizations. * Direct and coach the Medical Information Contact Center staff on handling of "routine" cases; monitor and manage complex "escalated" cases from the Medical Information Contact Center. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: * The qualified candidate will have a doctoral degree in a health sciences related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry. * 1-2 years of healthcare or related experience (managed markets, clinical practice, research or academic) following award of doctoral degree. * Possesses good communication skills, both oral and written, and able to engender trust and respect of peers, subordinates and superiors. * Well-versed in highly technical and scientific languages in order to communicate with key Thought Leaders, Medical Affairs, Research and Development, as well as other key internal and external stakeholders. * Firm understanding of the drug development process including key phases, processes, and techniques utilized for both pre- and post-marketing research studies. * Proven track record of teamwork, leadership, timely decision making and results orientation in meeting objectives. * Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook. TRAVEL REQUIREMENTS: * Overnight travel (10-20%), including some weekend commitments. * Travel may vary depending on therapeutic responsibilities. WHAT TAKEDA CAN OFFER YOU: * 401(k) with company match and Annual Retirement Contribution Plan * Tuition reimbursement Company match of charitable contributions * Health & Wellness programs including onsite flu shots and health screenings * Generous time off for vacation and the option to purchase additional vacation days * Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. Locations Lexington, MA Exton, PA Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda Pharmaceutical Company Ltd Exton PA

DHR Reviewer

Teleflex