Senior QA/RA Manager, IVD & IVDR Specialist

Cure Talent; Manchester; On-site; GBP 70,000 - 90,000; Full time

Job summary

Cure Talent are delighted to partner with an established medical device manufacturer in Manchester to appoint a senior QA/RA Manager. You will own day-to-day quality and regulatory activities, support the IVDR transition, manage the QMS and liaise with the notified body while coordinating with R&D and engineering teams.

This role is ideal for an experienced QA/RA professional from an IVD or medical device background who can work independently in a fast-moving, small and collaborative

Qualifications

• Senior, hands-on QA/RA role
• Ownership of day-to-day quality and regulatory activity
• Experience with ISO 13485 and IVDR
• Ability to interact with notified bodies and R&D/engineering teams

Responsibilities

• Maintain and improve ISO 13485 QMS
• Lead IVDR transition regulatory work and submissions
• Act as main internal SME for quality/regulatory matters
• Collaborate with R&D and engineering on product development and change control
• Shape regulatory strategy for expansion into multiple markets including EU and US

Skills

QA/RA management

IVDR knowledge

ISO 13485

QMS development

Regulatory submissions

Cross-functional collaboration

Job description

Cure Talent are delighted to partner with an established medical device manufacturer in Manchester to appoint a senior QA/RA Manager. You will own day-to-day quality and regulatory activities, support the IVDR transition, manage the QMS and liaise with the notified body while coordinating with R&D and engineering teams.

This role is ideal for an experienced QA/RA professional from an IVD or medical device background who can work independently in a fast-moving, small and collaborative