Austin Vita are working with a start-up Medical company that requires an interim Head of Regulatory and Quality to support the team in upcoming projects.

Responsibilities will include:

Leading a team of Quality/Regulatory Managers and Associates
Identify and report any quality or compliance concerns and take immediate corrective action as required
Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
Act as the primary contact for Notified Body and Competent Authorities
Lead QMS remediation activities, ISO 13485 in preparation for MDR and MDSAP.
Lead FDA interactions including RoW submissions

To be considered you must have:

* Ability to prioritise workload in a start-up environment across different projects
* At least 5 years’ experience in a QA/RA role relating to medical devices
* Comprehensive understanding and training with ISO14971 Risk Management
* Experience of start-up culture and ways of working is beneficial
* Excellent verbal and written skills
* Ability to prioritise workload in a fast-paced environment
* Experience with SaMD

Austin Fraser is acting as an Employment Business in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.