Regulatory Specialist

Contract Opportunity – QARA Specialist (Medical Devices)

Location: Fully Remote (UK-based preferred)

Commitment: 3 days per week

Rate: £40–£60 per hour (Outside IR35)

Contract Type: Contract

We are seeking an experienced Quality Assurance & Regulatory Affairs (QARA) Specialist to support our medical device operations on a contract basis. This is a fully remote role requiring 3 days per week, focused primarily on updating, maintaining, and improving quality and regulatory documentation.

Key Responsibilities:

• Update and maintain Quality Management System (QMS) documentation
• Review and revise technical files and regulatory documentation
• Ensure compliance with MDD, MDR, and FDA requirements
• Support internal quality processes and document control activities
• Assist with audit readiness and regulatory submissions where required
• Identify gaps in documentation and implement corrective updates

Requirements:

• Proven experience in the medical device industry (essential)
• Strong hands-on QMS experience (ISO 13485 preferred)
• Demonstrable experience working with MDD and MDR regulations
• Working knowledge of FDA regulations (21 CFR Part 820)
• Experience updating technical documentation and quality records
• Strong attention to detail and ability to work independently
• Excellent written documentation skills

What We Offer:

• £40–£60 per hour (depending on experience)
• Outside IR35 contract
• Flexible, fully remote working
• Opportunity to support a growing and dynamic medical device environment

If you are a detail-oriented QARA professional with strong regulatory knowledge and documentation expertise, we would love to hear from you.

To apply, please send your CV and availability details via LinkedIn!