Pharmaceuticals

IVD Consultant

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About the job

Do you have experience with medical devices and regulatory requirements? Are you looking for an exciting new career opportunity? 

Invenia Group has partnered with a renowned regulatory consultancy, based in Munich, Germany. The company is currently searching for an experienced IVD professional to join the growing team. This position will offer the correct candidate the opportunity to offer consultative advice to a range of companies in the industry and give a broad oversight of the market.

Role responsibilities: 

If successful, you will be responsible for advising clients on the technical, quality, and clinical aspects of combination products, while collaborating cross-functionally. You will ensure that the content of medical device work packages and documentation are appropriate and enable CE certification, as well as the following:

  • Perform gap analyses for regulatory compliance
  • Offer support with notified Body submissions (including NBOp as per MDR Art. 117, clinical investigation, 510(k)
  • Preparation of device-related module-3 sections for MAA and BLA/NDA submissions of drug-device combination products

What we are looking for:

We are looking for someone with a Ph.D. in a relevant scientific field and at least 5 years of industry experience. You should have an in-depth technical understanding of medical devices e.g. MDR, IVD, IVDR) and ISO 13485 (QA) and experience with medical devices and regulatory requirements for all device life-cycle stages and with relevant processes including risk management and usability engineering. Fluency in English and German languages is also a bonus. 

Sound interesting? To find out more information regarding this opportunity, please apply.