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Director of Quality and Regulatory
- Posted 22 August 2023
- LocationMickleton
- Job type Permanent
- Reference91930
- Contact NameLouise Cleland
Job description
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