Medical Devices

Director of Quality Assurance & Regulatory Affairs

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About the job

Do you have extensive experience (8+ years) in the regulatory field for medical devices of class 2b or higher? Are you seeking a new career challenge?

Invenias has partnered with a rapidly growing, highly innovative MedTech start-up company specializing in Surgical Robotics who is looking for a Quality Assurance & Regulatory Affairs Director to join the team.

This company have developed a Surgical Robot that has the potential to make a huge impact in their specialist field, improving the lives of millions of patients worldwide. The existing team is very dynamic and they are keen to find a highly motivated individual to pilot their reglementary activities.

Role responsibilities:

If successful, you will work alongside the CEO and the rest of the team to put in place a quality system, and organize the certification (CE and FDA) of their device. You will also be responsible for managing all key activities necessary to gain CE mark under MDR EU 2017/745, you will create a QMS (EN 13485), choose and manage interactions with the EU notified body, manage the necessary device tests (60601) for pre-certification and aid in the compilation and submission of ANSM & CPP documents needed for patient trials.

Working together with the clinical team and surgical partners, you will help pilot the pre-clinical and clinical tests, and working together with the engineering team you will also prepare the submission of the technical file redaction for CE mark, manage the handling of non-conformities, CAPA and continuous improvement processes and organize the FDA 510k certification process following CE approval.

What we are looking for:

To be considered for this role you will have extensive experience (8+ years) in the regulatory field for medical devices of class 2b or higher, experience putting in place a quality system, experience in surgical robotics and/or medical software is a plus, but not vital.

You should also possess a proactive personality with the ability to integrate with the existing a start-up team and excellent oral and written skills along with great team work skills and the ability to listen.

This role will be office based with part-time flexible hours a possibility (especially in the times of Covid-19).

Interested? Apply via the following link to find out more regarding this opportunity.