My client is the largest medical device consultancy in Europe, focusing on a wide variety of sectors including diagnostics, medical devices, software as a medical device, surgical & combination products just to name a few.

This is a great opportunity for someone looking to be apart of a family and to help shape the development of the team and the positioning QARA capabilities both internally and with clients. You will work within a diverse and inclusive environment, where everyone genuinely wants to see you succeed and develop in your career.

Please see below:

Responsibilities:

• Responsible for growing and leading a high performing team of QA and RA professionals
• Drive QARA capabilities with clients
• Provide support to global clients in developing regulatory strategies and support the project teams in creating technical documentation
• Update, maintain and continually improve the QMS
• Build relationships with stakeholders and drive commercial awareness to medtech within the business
• 60/40 split to RA and QA activities
• Support client audits

Requirements

• Bachelor's degree in a scientific field
• Extensive experience (approx. 10-20 years) in regulatory compliance for medical devices for EU/FDA markets
• Strong experience with ISO13485 & FDA QSR QMS
• Ability to build relationships and influence stakeholders
• Experience compiling technical documentation
• Experience in a consultancy environment is an added bonus