Product Surveillance Coordinator

232007

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

**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.

**Responsibilities**:

- 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.

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.

Our Talent Acquisition Team welcomes your questions at +49 (0)89 4612 2800 or toll-free at +800 4612 2800.

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