Post Market Surveillance Coordinator-Remote

W L Gore & Associates - Flagstaff, AZ

Full-time

Remote - Flagstaff, AZ

Electrical Equipment, Appliance, and Component Manufacturing

About the position

We are looking for a Post Market Surveillance Coordinator to join our Post Market Surveillance Team. This role will be responsible for the management and reportability assessment of adverse events, complaints, and product feedback for Gore medical products. The ideal candidate will possess 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

Requirements

• Bachelor's degree in a scientific discipline, OR minimum of 6 years of healthcare or medical device industry work experience, OR Bachelor's degree in a non-scientific discipline AND minimum of 3 years of healthcare or medical device industry work experience
• Experience in medical device reporting (MDR) submission to regulatory body
• Solid, fundamental understanding of (or willingness to learn) medical terminology and anatomy
• Strong communication skills (verbal and written), 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
• Ability to work under and meet deadlines imposed by governmental regulations

Nice-to-haves

• Educational background and/or work experience in health care, or a related field
• Gore Product Surveillance Experience

Benefits

• Comprehensive and competitive total rewards program
• Distinctive Associate Stock Ownership Plan
• Potential opportunities for profit-sharing