Product Surveillance Coordinator - Putzbrunn, Deutschland - W. L. Gore & Associates

W. L. Gore & Associates

Geprüftes Unternehmen

Putzbrunn, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 stateofthe 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:

13 years of work experience in the medicaldevice 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 , ISO13485, EU MDR)
Strong organization and writing skills as well as direct communication style
Teamplayer 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 or toll-free at

**#LI-ENL