3Shape A/S Business Support

Global Post Market Surveillance Manager

The Regulatory Affairs team at 3Shape is expanding, and so are the requirements for surveillance of medical devices once marketed for clinical use in real-life settings. If you are ready to develop and implement the framework that takes our post-market surveillance approach to the next level, then 3Shape offers a unique opportunity to work as Global Post-Market Surveillance Manager in the center of Copenhagen at Kongens Nytorv. This opportunity will help you develop within future disruptive health technologies in collaboration with the wider 3Shape organization.

The company

3Shape´s growth has been steep for the last 15 years. From two guys with a business plan and a master’s thesis prototype to Denmark’s most successful medical device company with more than 1500 employees. No venture capital. No external investments. Just hard work, talent, and grit! A third of all 3Shape staff work in R&D. Innovation is a central part of ‘our DNA’ which fosters a culture of thinking differently. Emphasizing empowerment and taking ownership are key aspects of our culture. We are no longer a start-up, but we take pride in continuing to think like one – together we embrace new ways to exchange ideas and develop unprecedented innovations. All of this helps us to stay engaged with a broad canvas of technologies and applications within dentistry. We simply think and work in an agile way.

Our team

Currently, we are 3 Scientific Managers and part of the global RA/QA organization consisting of 9 Regulatory Affairs Specialists/Coordinators, 6 Product Quality Managers/Engineers and 3 Regulatory Affairs Specialists located in Brazil, Korea and Japan.

You will report to the Head of Scientific Affairs and you will be part of our growing global RA/QA organization based in Copenhagen, which currently includes around 20 people. You will interact with a wide range of stakeholders and especially with Development, Customer Support, Product Management and external consultants worldwide.

Your key responsibilities:

Your main responsibility is to develop and implement our new PMS approach based on current and evolving global regulations including EU MDR and MDSAP. In order to do so, you will lead and facilitate the following activities:

  • Collect and interpret relevant PMS data from multiple stakeholders, including writing PMS plans, PMS reports, and Periodic Safety Update Reports
  • Provide a clinical safety and usability perspective to the overall Risk Management Process and individual Product Risk Assessments
  • Interact with authorities to fulfill the regulatory requirements related to PMS, Vigilance, and Trend Reporting (e.g., reporting of serious incidents and Field Safety Corrective Actions)
  • Upload relevant documentation to the EUDAMED database
  • Support the organization during internal and external audits
  • Contribute to continuous improvement of PMS processes and procedures and conduct training as appropriate 

Your profile:

As a person, you are a good team player with strong interpersonal skills who thrives in working with multiple stakeholders and partners, both internally and externally. Also, you have the ability to successfully handle multiple tasks while managing tight deadlines and at the same time, you are flexible and know how to reach agreements through dialogue and compromise.

Furthermore, you have:

  • Bachelor or Master’s degree in Life Science or Engineering
  • Relevant Quality, Regulatory or Vigilance operational experience from the medical device industry
  • Understanding of EU and/or global medical device regulations/directives, including ISO‑13485 and ISO-14971
  • Structure to drive processes forward
  • Excellent planning, cooperation, and communication skills
  • Fluent in written and oral English

We offer:

  • A professional challenge in a dynamic, globally-oriented business environment
  • The chance to influence the future of a fast-growing innovative company
  • An opportunity to become part of a successful, enthusiastic, international team in an informal workplace
  • A competitive salary and benefits
  • A great location in downtown Copenhagen

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Reference No.:

NBH

Region:

  • Region Hovedstaden

Job type:

Regular

Working hours:

Full-time

Working days:

Day

Location:

Copenhagen

Contacts:

Yaron Y. Levy

Mobile: +45 31124091

Company homepage:

http://www.3shape.com

Office address: