Regulatory Affairs


What we do

The Regulatory Affairs team is growing rapidly as is the company’s requirement for a faster time to market for its solutions. Our responsibilities include obtaining and maintaining regulatory approvals for 3Shape 3D scanners and software medical devices as well as providing global registration support for the organization.

By interacting with a wide range of stakeholders -especially R&D, Product Management, global sales offices and external consultants - we are supporting and monitoring the development of future disruptive health technology.

Our team

Our team consists of Regulatory Affairs Specialists, Product Quality Managers, and Scientific Managers with diverse backgrounds. We are located in Denmark, Brazil, Korea and Japan.

Our people love working here

As a regulatory affairs specialist in 3Shape, you work with different departments and teams. It creates a very diverse set of tasks, which I like. There are moments when you need to step out of your comfort zone and try new ways of understanding and solving problems.

Ewa Wybraniec Regulatory Affairs Specialist

I get to work with cutting edge tech and the latest in the regulatory affairs landscape. It is super exciting to bring truly novel dental technologies to global markets.

Shreyosi Chakraborty Regulatory Affairs Specialist

Holmens Kanal 7
1060 København Directions View page

AU - Sydney

2000 Sydney Directions View page

BR - São Paulo

Av. das Nações Unidas, 12901
04578-910 São Paulo Directions View page

CN - Shanghai

Kaixuan North Road
200060 Putuo Qu Directions View page

CO - Armenia

630003 Armenia Directions View page

CO - Bogotá

111121 Bogotá Directions

DE - Düsseldorf

Volmerswerther Str. 41
40221 Düsseldorf Directions View page

ES - Madrid

Calle Acanto, 22
28045 Madrid Directions View page

FR - Paris

254 Rue du Faubourg Saint-Honoré
75008 Paris Directions View page

IT - Milano

Via Giuseppe Ripamonti, 137
20141 Milano Directions View page

JP - Tokyo

2-chōme-11-2 Nishiazabu
106-0031 Minato City Directions View page

KO - Seoul

135-091 Gangnam-gu Directions View page

PL - Szczecin

Południowa 27c
71-001 Szczecin Directions View page

UA - Kyiv

Polova St, 21
02000 Kyiv Directions View page

UK - Reading Berkshire

Multipurpose Sports Court, Green Park Reading
RG2 6GP Reading Directions View page

US - Durham, NC

27701 Durham Directions View page

US - New Providence, NJ

430 Mountain Ave
07974 New Providence Directions View page

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