Specialist Software

Description:

In this position you will assess the most innovative software products coming to the market: from startups and global corporations alike. You will be a part of brand that is renowned worldwide and ensure their reputation remains unrivalled. This is a chance to have the responsibility to aid manufacturers seeking a CE mark by performing conformity assessment activities and get the life-saving software to market as quickly and smoothly as possible. As well as working in these technical activities, you will have the opportunity to optimise processes internally making them more efficient and leaving a legacy within the business.

The role is uniquely structured, so that there is very limited travel.

🔹 As Product Reviewer - software you will:

• Plan, oversee and execute the entire conformity assessment project plan from A-Z
• Assess manufacturer documentation for CE marking according to MDR 2017/745
• Provide input/recommendations to the audit team on areas of focus for QMS audits, based on your experience of reviewing the technical documentation
• Manage compliance and regulatory activities related to the notified body
• Optimise and improve processes internally to make them more efficient and effective

This is a great opportunity to be at the forefront of the newest, cutting edge technology. If you have previously worked in industry in a regulatory affairs/R&D role with software devices and want to widen your product scope instead of being limited to one company, and work from home with limited travel then this could be the perfect opportunity for you.

🔸 Requirements:

• Bachelor's, Master's or PhD in relevant science or engineering
• 4+ years of experience in the medical device industry
• Previous experience working in a notified body