Product Surveillance Coordinator (f/m/d)
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 Product Surveillance Coordinator (f/m/d) to join our Medical Product Division in Putzbrunn, who will evaluate and respond to customer complaints related to our medical device products. In this role you are ensuring that Gore responds appropriately to potential issues involving state-of-the art implantable medical devices.
This position will be located at our facility in Putzbrunn, Bavaria, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.
- Receive, evaluate, and investigate customer complaints related to our implantable medical device products
- Ensure that we respond appropriately to potential issues involving state-of-the art implantable medical devices to the Notified Body, National Competent Authorities, as well as the FDA (Food and Drug Administration)
- Report adverse events to National Competent Authorities, as well as the FDA
- Interact closely with colleagues of different functions across the world
- Maintain and support procedures and processes, and report guidelines
- Support periodic trend analysis, risk analysis/FMEA, and design control activity
- Assist in decision making and provide recommendations associated with corrective and/or preventive actions
- Deliver training internally and externally related to product surveillance activities
Required Qualifications:
- 1-3 years of work experience in the medical-device industry or a bachelor’s degree in a related scientific field; we are open for junior as well as for experienced profiles
- Good understanding of medical terminology and anatomy
- Understanding of global regulations, standards, and industry terminology related to global product surveillance of medical devices
- Working knowledge of worldwide regulations related to Product Surveillance (eg: 21CFR 820.198, ISO13485, EU MDR)
- Strong organization and writing skills as well as direct communication style
- Team-player with the ability to work independently in a diverse team across regions and functions
- Dedication to details, governmental regulations, and strict timelines
- Flexibility and ability to prioritize and handle multiple tasks/projects
- Ability to travel occasionally (up to 10%)
- Fluent in German and English
Desired Qualifications:
- Educational background and/or work experience in health care, medical coding, or a related field
- Demonstrated experience supporting audits or regulatory response communications with successful results
- Experience within Product Surveillance software system SmartSolve
Hybrid Working Arrangements are permitted with appropriate approval and compliance with Gore’s policy.
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, Associate Stock Ownership Plan, company pension plan, childcare subsidies, generous holiday entitlement, flexible working program as well as subsidized cafeterias and coffee areas. 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.
At Gore we are looking for qualified and motivated individuals. We welcome all applications irrespective of social and cultural background, age, gender, disability, sexual orientation or religious belief.
Our Talent Acquisition Team welcomes your questions at +49 (0)89 4612 2800 or toll-free at +800 4612 2800.
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About Gore
For 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development. Consider how you can grow your impact with Gore. Learn more at gore.com