Senior Regulatory Affairs Consultant (US) (f/m)
Confinis is always looking for talented people to become its team members. We realize that productive people are always a good addition to our organization. So if you have the financial acumen and the passion to work with some of the biggest companies in the world, join in!
Within this role you will be responsible for the following tasks
- Performing mock-inspections according to FDA’s QSIT
- 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 regulatory strategies for medical device and combination product manufacturers
- Establishing briefing books for scientific advice meetings with the US FDA
- Initiating, coordinating and participating scientific advice meetings with the US FDA
- 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, biochemistry or pharmacology and 5+ years’ experience as an investigator 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.