IVD Regulatory Affairs Consultant

As a Regulatory Affairs Consultant at our company, you provide specialist consulting services directly to customers. This could involve supporting customers with FDA pre-submissions and 510(k) clearances , their transition from the IVDD to the IVDR gaining CE certification, approvals in other global markets for the first time, or preparing regulatory strategies.

As a consultant, no two days or customers are the same. You may be engaged to build a 510(k) submission or technical file reports to support CE certification, or similar global approvals. However, it could also include developing a regulatory strategy, product development planning, in-depth reviews of performance evaluation or risk management data, creating and reviewing quality management system policies and procedures, performing gap analyses, internal or supplier audits to support and improve customers quality systems or perhaps delivering customer training.

Our clients include the full spectrum from top 50 global IVD companies and pharma corporations with companion diagnostics to start-ups that we help to bring new innovations to global markets.

You will be part of a team. No one is an expert on everything, so we support each other to play to our strengths so that we provide the best service to customers. This position is a great opportunity to apply your expertise and continue to build your experience. We know how important it is for our customers that we maintain our experience to be state-of-the-art and we, therefore, hold monthly Qserve training days to ensure we provide consistent advice to customers as well as to continue to learn from each other.