Quality & Regulatory Administrator – ISO 13485 & QMS

Millbrook Group Ltd; Eling; On-site; GBP 51,000 - 85,000; Full time

Benefits offered by this job

40h/week

Holiday 25 days + bank holidays

Company Pension

Sick Pay

Life Assurance

Rewards scheme

Job summary

Millbrook Healthcare Group is seeking a Quality Administrator to join the Ultimate Healthcare team. The role supports the SHEQ Department with administration for Quality and Regulatory Compliance to ensure operational integrity and market reputation.

You will assist in audits, document control, procedure development, supplier management, and ISO compliance, helping secure new accreditations and maintain compliance across the business.

Qualifications

• Excellent verbal and written communication skills.
• Proven team player with the ability to use own initiative.
• Able to adapt to change and approachable with influencing and listening skills.
• Proficient in IT software including Microsoft Office including OneDrive, Share Point, Teams.
• Excellent time management in regard to achieving deadlines, adhering to training schedules and travelling.
• Experience of document control
• Desirable: An understanding of technical documentation
• Desirable: Ability to communicate to third parties
• Fundamental comprehension of ISO compliance
• Desirable: some knowledge of regulatory compliance
• Experience of document control
• Experience of working within systems in a highly regulated industry
• Desirable: exposure to the Medical Device sector
• Experience of ISO standards

Responsibilities

• Assisting in the QMS system and supporting in the ISO 13485 compliance including:
• Supporting internal audits (collating data, writing up findings, obtaining sign offs).
• Investigating product / process failures as required.
• Being a part of supplier management team.
• Play a key role in Procedure development, writing and implementation.
• Co-review documentation, and being pivotal in the document control and document change process.
• Where required, being part of the team to create any required documentation.
• Assisting in Health & Safety management on site.
• Assist in implementation of systems/processes/Procedures where required.
• Undertake the job in line with the company appraisal competencies.

Skills

Communication

Team player

Adapt to change

MS Office

Time management

Document control

ISO compliance

Regulatory compliance

Regulated industry

Medical Device sector

Tools

OneDrive

SharePoint

Teams

Microsoft Office

Job description

Millbrook Healthcare Group is seeking a Quality Administrator to join the Ultimate Healthcare team. The role supports the SHEQ Department with administration for Quality and Regulatory Compliance to ensure operational integrity and market reputation.

You will assist in audits, document control, procedure development, supplier management, and ISO compliance, helping secure new accreditations and maintain compliance across the business.