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!