Job Description
Cure Talent is delighted to be working with a fast-growing specialist consultancy that delivers tailored Quality and Regulatory support to some of the UK’s most exciting MedTech innovators.
Due to their exceptional continued growth, we’re looking for a QARA Consultant with a strong focus on Quality Assurance to support clients across the Midlands region – from early-stage start-ups building their QMS from scratch to established companies navigating remediation, audit readiness, and compliance improvements.
This is a hands-on, client-facing role supporting multiple high-impact projects while collaborating with a forward-thinking team of quality & regulatory professionals.
You will:
1. Lead QMS development, implementation, and ongoing maintenance in line with ISO 13485, 21 CFR Part 820, and MDSAP requirements.
2. Provide guidance on quality system gaps and deliver remediation plans to ensure audit readiness.
3. Support internal and external audits (Notified Bodies, MDSAP, FDA), including mock audits, CAPA management, and audit defence.
4. Deliver operational quality support – from document control, SOP development and training, to batch review, DHRs, and NC investigations.
5. Collaborate closely with RA, design, clinical, and operations teams to embed robust, compliant quality processes...