Regulatory Affairs & QMS Administrator

FMC Talent; England; On-site; GBP 17,000 - 22,000; Part time

Job summary

A dynamic orthopaedics company is seeking a part-time regulatory administrator to support their quality and regulatory teams. In this role, you'll ensure compliance processes are maintained and documentation is managed effectively. This position allows flexibility to fit around personal commitments, making it ideal for those seeking balance in their work life. You'll join a friendly, collaborative team focused on quality and accuracy in a growing business environment.

Qualifications

• Experience in a regulatory or quality-focused admin role.
• Familiarity with document control processes.
• Ability to maintain quality management systems.
• Love getting into nitty gritty and thrive on detail

Responsibilities

• Ensure processes related to quality/regulatory compliance are maintained.
• Manage the document control process.
• Update policies, procedures, and forms relating to QMS.
• Administer the CAPA process for the business.
• Coordinate internal processes and handle complaints.
• Monitor field safe notices and compile information for reviews.
• Prepare information required for quality management reviews
• Support regulatory compliance activities and audits

Skills

Attention to detail

Admin skills

Time management

Communication

Education

Internal audit qualification

Experience in ISO13485 or ISO9001

Job description

This is a Part-time position, between 16-20 hours a week.

You’re comfortable working where detail matters. Managing documentation, supporting compliance processes, and keeping quality systems running smoothly behind the scenes. You’ve built experience in a regulatory or quality-focused admin role, and you take pride in keeping things accurate, organised, and audit-ready.

This role gives you a chance to use that experience, and – because it’s a part time role – it’ll also work around you and your life. It's perfect for someone who wants a role that fits with school hours, or over fewer days per week. As long as you can get the job done, it'll fit around your life, not the other way round.

And it’s not just the hours that make this a great fit. You’ll be joining a tight-knit, growing orthopaedics business that’s growing steadily. The team’s supportive and collaborative, so you’ll be surrounded by people who help each other out.

Who’s it for?

Our client is a dynamic orthopaedics company that is growing year after year. In this role, you’ll join a close-knit and vibrant team with real spirit – if you’re a good team player, you’ll fit right into the collaborative, supportive environment that they offer.

What will your day to day look like?

You’ll support the quality and regulatory teams with keeping their processes and procedure in good shape. An average week might include:

• Ensuring processes related to quality/regulatory compliance are maintained
• Managing the document control process
• Updating policies, procedures and forms relating to QMS and regulatory compliance
• Administering the CAPA process for the business
• Coordinating the internal IL process, including managing updates and handling complaints
• Administering any product recall activities
• Monitoring MHRA field safe notices
• Compiling information required for quality management reviews
• Assisting with product registrations

This role will suit you if you…

• Have experience in an ISO13485 or ISO9001 certified business (or other regulated industry)
• Have an internal audit qualification or experience performing them
• Are great at admin, communication and time management
• Love getting into the nitty gritty and thrive on detail

Think this could be your next role?

Then we’d love to hear from you! If you’re interested in applying or would like to see the full job description for this role, please get in touch with Frankie on [e-mail]

The fine print

Reference number: 21833

Temporary or Permanent: Permanent

FMC contact for this role: Frankie Garrod