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Post Market Surveillance Coordinator-Remote

W.L. Gore & Associates, Inc.
Flagstaff, AZ Remote Full Time
POSTED ON 7/4/2023 CLOSED ON 7/9/2023

What are the responsibilities and job description for the Post Market Surveillance Coordinator-Remote position at W.L. Gore & Associates, Inc.?

Job: Clinical/Regulatory
Primary Location: Americas-US-AZ-Flagstaff
Other Locations: Americas-US-AZ-Phoenix
Travel%: 5%
Shift: Day
Schedule: Full-time

Post Market Surveillance Coordinator-Remote-231741


About Us:
Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.


About the Industry:
Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries


About the Role:
We are looking for a Post Market Surveillance Coordinator to join our Post Market Surveillance Team in the United States. This role will be responsible for the management and reportability assessment of adverse events, complaints, and product feedback for Gore medical products. This role requires a willingness and capacity to collaborate across multiple functions within the business, manage various projects and communicate progress of these projects internally and externally.

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities:
  • Develop working knowledge of applicable domestic and international regulations and thorough familiarity and understanding of internal standard operating systems and procedures
  • Provide regulatory Medical Device Reporting (MDR) to the FDA for Gore medical devices
  • Communicate internally with local associates within the business, including product specialists, sales associates, quality assurance, engineering, and other related functional areas
  • When dealing with international complaints, ensure that any necessary reporting and communication occurs in an appropriate and timely manner
  • Work with product teams to define/categorize potential complaints and MDRs based on training and anticipated and/or previously identified events
  • Work with product teams to support periodic trend analyses as well as decisions and recommendations associated with corrective and/or preventive action(s), risk analysis/FMEA, revision/initiation of MDR reporting guidelines, and design control activity
  • Maintain compliance with training expectations as required for this position
  • Perform additional responsibilities as required within the scope of position

Required Qualifications:

  • Bachelor's degree in a scientific discipline, OR Bachelor's degree in a non-scientific discipline plus a minimum of 3 years healthcare or medical device industry work experience, OR a minimum of 6 years healthcare or medical device industry work experience
  • Experience submitting medical device reports (MDRs) to a regulatory body
  • Solid, fundamental understanding of (or willingness to learn) medical terminology and anatomy
  • Strong communication skills (verbal and written) and experience with medical writing
  • Attention to detail and organizational skills
  • Competency in Microsoft Office Suite
  • Flexibility and ability to prioritize and handle multiple tasks/projects
  • Ability to work and problem solve independently, as well as part of a team
  • Ability to work with multiple functional areas in multiple physical locations and to work under and meet deadlines imposed by governmental regulations
  • Ability to travel up to 5%

Desired Qualifications:

  • Educational background and/or work experience in health care, or a related field

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).

What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers

We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
Gore is a M/F, Disabled and Vet EEO/AA employer. (Applies to all positions in the U.S.)
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
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