European Union Regulatory Affairs, Quality/Risk Management
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. We have been changing lives and changing industries including medical devices, fabrics, electronics, and manufacturing for more than 55 years.
Those who choose Gore, want to discover and explore new ways – using their passion and knowledge. Where doing so as part of a strong and engaged network is as important as individual performance.
European Regulatory Affairs Coordinator (f/m)
Location: Putzbrunn, greater Munich or Home Office based
Job Number: 171986
Our Medical Products Division is looking for a highly experienced European Regulatory Affairs Coordinator (f/m), ideally based in our Munich office, or home office based.
As European Regulatory Affairs Coordinator (f/m) you will provide regulatory expertise and coordination to ensure completion of Gore′s European regulatory affairs activities. In this role, you will be the subject matter expert for the region who enables the efficient achievement and maintenance of the CE mark across product lines. Fostering and maintaining key relationships with Gore’s Notified Body and other European regulatory affairs organizations will be also one of your responsibilities. You will serve as key adviser and project team member to implement the MDR into the Quality System. Due to your deep understanding of the European environment and business needs you will establish best practice for European regulatory activities and ensure consistent application across all product lines. Working with other Regulatory Affairs and Clinical associates you will develop and drive our European Regulatory strategy. This entails planning short and long term regulatory resource needs. If you are looking for a company where you can make a difference, we are looking for you!
Several years as a Regulatory Affairs Professional with Class III device design dossier experience under the European Medical Device directive.
Bachelor degree (or equivalent) in science or medical fields preferred, RAC-certification is a plus.
Strong influencing skills in a complex, cross-functional organization and demonstrated ability to negotiate with and influence European notified bodies.
Demonstrated ability to organize and complete complex projects on time and in compliance with requirements.
Fluent English, additional language skills will be an asset.
Passion about Regulatory Affairs for state-of-the-art implantable medical devices and energy for the dynamic area of European medical device regulations.
Be eager to build internal and external relationships to optimize business results.
The Fine Print: In addition to interesting job opportunities and a unique culture, Gore offers its Associates many attractive benefits: work-life balance and sports programs, attractive social benefits, childcare subsidies, generous holiday entitlement, flexible workplace design and working practices, diversity initiatives, as well as subsidised cafeterias and coffee areas.
You want to make a difference? Please apply online via: gore.com/change-life Our Recruiting Team will be pleased to answer your questions on +49 (0)89 4612 2800 or toll free on +800 4612 2800.