Regulatory Affairs Associate
Posted on Feb 2, 2019 by WL Gore & Associates GmbH
Discover how a team of Gore Associates,
including Hannah and Sarah, developed
Gore's Septal Occluder product to change
the way doctors treat patients with a
serious heart defect. And find out how
working at Gore changed their lives, too.
What can you change?
Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork.
Through our product leadership, we have been changing lives and changing industries including medical devices,
fabrics, electronics, and manufacturing for more than 60 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.
Regulatory Affairs Associate (f/mid)
Standort: Europe (France, UK, Germany, Netherlands or home based)
SOur strong medical division is looking for a person being a vital partner in ensuring the continued commercial success in the
EMEA region by coordinating and preparing regulatory submissions in support of business objectives. You will be managing
regulatory submissions in EU, including interaction with Notified Bodies and coordination of MDR EUDAMED information
maintenance. Developing, coordinating and ensuring completion of local country registration activities in EMEA will be part of your
responsibility as well as ensuring compliance with relevant laws and policies. You will be working closely with the relevant
stakeholders to develop strategies for obtaining regulatory approvals in the (E)EMEA regions. You are a strong networker who
loves to navigate the ever-changing regulatory environment and contribute to the success of the business.
* College degree, ideally in biology, chemistry, engineering, medicine, law or allied health sciences field.
* At least 3-5 years' experience in a regulatory role in the medical device or pharmaceutical industries, including identifying and
meeting submission requirements.
* Knowledge of the European Medical Device Regulation (EU/2017/745).
* Very good English oral and written communications skills. Any other European language is a plus.
* Understanding of regulatory requirements in EMEA for medical devices and high attention to details.
* Computer savviness.
* International travel up to 20%.
The Fine Print: In addition to interesting job opportunities and a unique culture, Gore offers its Associates many attractive benefits: work-life 18
balance and sports programs, attractive social benefits, childcare subsidies, generous holiday entitlement, flexible workplace design and BesteMbeltember
working practices, diversity initiatives, as well as subsidised cafeterias and coffee areas. Deutschland
You want to make a difference?
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