Quality & Regulatory Specialist – Medical Devices

Fully Remote – UK
Permanent | Full Time

CY Partners are working with a growing specialist consultancy to recruit a Quality & Regulatory Specialist to join their Medical Device and International Standards team.

This is an opportunity to work across a varied portfolio of client projects, supporting organisations with the quality, regulatory and technical challenges involved in developing and bringing medical technologies to market.

Rather than being focused on one product or organisation, you'll work with different clients and technologies, collaborating with experienced specialists across the business and taking responsibility for delivering your own projects.

What will you be doing?

Your work will be varied and could include:

• Developing regulatory strategies for clients

• Performing gap analyses and audits

• Advising clients on medical devices and management systems

• Creating and reviewing technical documentation

• Designing, implementing and supporting management systems

• Managing projects from initial scope through to delivery

• Working closely with colleagues from other specialist areas to provide joined-up support to clients

• Managing multiple client projects and priorities simultaneously

What are we looking for?

You don't necessarily need to tick every box.

We're interested in people who already have experience within medical devices, quality, regulatory affairs or another relevant regulated environment and who are comfortable working directly with clients and managing projects.

Experience in any of the following would be particularly useful:

• Medical Device Technical Documentation

• ISO 13485

• ISO 27001

• Gap analysis and auditing

• Quality or management systems

• Process and procedure development

• Software development or testing

• AI development or testing

• GDP, GMP or GCP

• IATF 16949 or AS9100

Just as importantly, you'll need to be organised, comfortable managing competing priorities and confident communicating technical or regulatory information to different stakeholders.

Why consider it?

The role is fully remote within the UK, with flexible working and face-to-face team events approximately once per quarter, with expenses covered.

You'll join a growing area of the business and work alongside experienced specialists and consultants with exposure to a broad range of clients and projects.

The company also offers private healthcare and, for the right person, support towards relevant professional certifications such as CQI, IRCA or RAPS/RAC.

Applicants must already be entitled to work in the UK.

If you're working within Medical Device Quality or Regulatory Affairs and would like a role offering greater variety, client exposure and the flexibility of working remotely, we'd be interested in speaking with you.

CY Partners Recruitment Ltd is acting as an Employment Agency in relation to this vacancy.