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Senior Regulatory Affairs Consultant (US) (f/m)

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Senior Regulatory Affairs Consultant (US) (f/m)

Within this role you will be responsible for the following tasks:

  • Establishing regulatory strategies for medical device and combination product manufacturers
  • Assisting our clients regarding regulatory submissions in the US (510(k)s, PMAs, NDAs, BLAs etc.), especially with regard to high risk medical devices and combination products
  • Establishing briefing books for meetings with the US FDA
  • Initiating, coordinating and participating meetings with the US FDA
  • Performing mock-inspections according to QSIT
  • Establishing and providing training regarding US regulations (21 CFR Part 210/211, Part 600, Part 820, Part 4)
  • Contributing to the continued successful growth of confinis as a leading provider of regulatory affairs services

For this position we are looking for person with a degree biomedical engineering or pharmacology and 5+ years’ experience as a regulatory officer with the US FDA who is looking to develop his career with a top notch regulatory consultancy active for the most successful and/or innovative medical device and combination product manufacturers.

With your excellent interpersonal skills you have the ability to communicate at all management levels and have a client-oriented mindset. You are a highly organized person who is able to set priorities and will persevere to make sure tasks are completed on time and in the quality expected by our demanding clients. 

Good English skills are essential, German and French a plus.

We look forward to receiving your application via email .

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