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Are you ready to pursue your scientific career within digital health working with 3D scanners as well as software medical devices in a global setting? Then 3Shape offers a unique opportunity to work as a Scientific Manager in the center of Copenhagen at Kongens Nytorv. This opportunity will help you develop within future-disruptive health technologies by being part of building and shaping the scientific foundation of our products globally.

About the department
As Scientific Manager, you will be part of our growing Global RA/QA organization based in Copenhagen, which currently includes one other Scientific Manager. You will interact with a wide range of stakeholders and especially with R&D, Product Management, Global Sales offices, and external consultants worldwide.

The Job
The main purpose of the job is to develop and maintain our clinical evidence documentation as well as to facilitate post market activities in order to support our products with regards to safety and clinical performance as well as claims. You will be cooperating with multiple stakeholders internally as well as externally.

Job responsibilities include:

  • Preparation and maintenance of Clinical Evaluation Reports (CERs)
  • Ensure that the clinical evidence requirements and the CERs for our products comply with current and future global medical device guidance and regulations
  • Define and coordinate Best Practice for Clinical Investigations / Evaluation Protocols including defining data collection, data management, and statistical methods
  • Planning and coordination of Investigator-initiated clinical investigations and other collaborations with external investigators
  • Provide support to product development teams regarding clinical aspects
  • Provide support to product marketing campaigns with regards to clinical claims based on clinical evidence
  • Contribute to continuous improvement of processes regarding clinical evidence
  • Answer questions from health authorities and from company affiliates/resellers regarding clinical safety and performance

Your profile
We are looking for a person with

  • Minimum a Master’s degree within a scientific field and preferably a Ph.D.
  • Minimum 3 years of relevant clinical/dental/medical writing experience
  • Experience within academia, preparation of scientific articles (including statistical understanding) is an advantage
  • Excellent planning, cooperation, and communication skills
  • Fluent English, written and verbally
  • Previous operational experience with product evaluations and/or clinical studies including regulatory submissions
  • Knowledge of medical device regulations and GCP (ISO or ICH)

As a person, you are a skilled team player with strong interpersonal skills who enjoys working with different stakeholders and partners, both internally and externally. Also, you have the ability to successfully lead multiple projects and simultaneously manage tight deadlines.

We offer

  • A professional challenge in a highly-dynamic, globally-oriented business environment
  • The chance to influence the future of an expanding company
  • An opportunity to become part of an enthusiastic and international team in an informal workplace
  • A competitive salary and benefits
  • Nice offices in downtown Copenhagen

Apply for this position already today and upload your transcripts together with your CV and cover letter as we interview continuously. Please apply via the link “Ansøg”. We look forward to hearing from you!

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

Please write in your application that you've seen the job at Jobfinder

København K
01. marts 2018
01. april 2018
Yaron Y. Levy
Tlf.: +45 3112 4091

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