Post Market Surveillance Coordinator-Remote
Job description
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. 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
- 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 at least 3 years of healthcare or medical device industry work experience, OR at least 6 years of 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. Locations not eligible for new remote work arrangements include: 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.
caravetterealestate.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caravetterealestate.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, caravetterealestate.com is the ideal place to find your next job.