3Shape A/S Scanner Development

Regulatory Affairs Specialist for electronic medical devices

We seek a Regulatory Affairs Specialist to join our Market Access team based in Copenhagen. Your main role is participating in obtaining and maintaining regulatory approvals for our intra oral scanners (TRIOS). You will take responsibility for national submissions to enable fast market access and will be in direct contact with consultants and relevant notified and regulatory bodies globally.

At 3Shape, Innovation is our DNA and hence we often introduce new products. While your first priority is on national product registrations, you will also engage in development of future products and our internal RA projects, such as the new Medical Device Regulation, MDSAP and process improvements.

As a member of our newly formed Market Access team you will be part of R&D but will also communicate with a broad range of stakeholders including sales, product management and our central RA division, with whom we are collocated one day per week.

In order to work at your best, you will have the possibility to influence the content of your role according to your specialization and the career path you want to follow. At 3Shape we value empowerment and work towards the common goal of improving people’s lives.

Your profile

You are a hands-on, implementer who enjoys working in a cross functional team, and further has most of the following qualifications:

  • A Master’s degree within engineering, natural sciences or similar
  • Ability to find the fastest path to market access for our products
  • Regulatory experience within the medical device industry
  • Experience with CE marking, MDR and 510(k)
  • Knowledge of the regulatory landscape in e.g. China, Japan, Brazil and Korea
  • Experience with production or development of medical devices

We offer

  • A professional challenge in a highly dynamic globally oriented business environment
  • Becoming part of a successful, enthusiastic, international development team in an informal workplace
  • Competitive salary and benefits
  • A great location in downtown Copenhagen

Need for more information?

Please contact Head of TRIOS Product Lifecycle and Market Access, Lasse Leick, at +45 50 90 91 93.

Application

Applications will be processed continuously so do not hesitate to apply for this exciting opportunity at one of Denmark’s most successful and fastest growing Medtech companies.

Read more about working at 3Shape at www.3shape.com/Corporate/Careers

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Reference No.:

NBH

Region:

  • Region Hovedstaden

Job type:

Regular

Working hours:

Full-time

Working days:

Day

Application deadline:

asap

Expected Start Date:

asap

Location:

København K

Contacts:

Lasse Leick

Mobile: +45 70272620

Company homepage:

http://www.3shape.com

Office address: