About the job

Cure Talent are delighted to be partnered with an established medical device manufacturer operating in the diagnostics space.

Due to continued growth, they are now looking to appoint a QA/RA Manager to join their Quality & Regulatory team based in Manchester. This is a great opportunity to join an innovative business and play a key part in supporting its ongoing regulatory journey and wider market expansion.

This is a senior, hands-on QA/RA role with responsibility for maintaining and developing the quality management system while driving regulatory strategy across current and future markets. You will take ownership of day-to-day quality and regulatory activity, supporting technical file preparation, submissions and interactions with the notified body, while helping to keep the business on track through its IVDR transition.

The role will also involve acting as the internal SME and primary point of contact for quality and regulatory matters, working closely with R&D, engineering and other stakeholders to ensure compliance is embedded across the business. Although this is not a traditional people management role, it will suit someone who enjoys taking ownership in a small, agile and collaborative environment.

You will be an experienced QA/RA professional from an IVD or medical device background, confident working independently and making decisions in a fast-moving environment. You will combine strong regulatory knowledge with a practical approach to QMS management, and be comfortable partnering closely with technical teams to get things done.

Role Responsibilities

• Maintain, improve and document the ISO 13485 QMS, ensuring it remains compliant and suitable for a business that is scaling.
• Lead regulatory work linked to the IVDR transition, including technical file preparation, submission support and notified body communication.
• Act as the main point of contact for quality and regulatory matters, both internally and externally.
• Partner with R&D and engineering to support product development, change control and ongoing compliance activities.
• Help shape regulatory strategy for expansion into additional markets, including the EU, FDA and Middle East.

Key requirements / What we look for

• Experience in RAQA within IVD or medical device design and manufacturing, ideally in a hands-on SME environment.
• Strong working knowledge of ISO 13485 and IVDR, with practical experience preparing technical files, supporting submissions and responding to notified body questions.
• Proven experience maintaining, updating and improving an ISO 13485 quality management system.
• Confidence operating as the internal subject matter expert, taking ownership of day-to-day quality and regulatory decisions.
• Comfortable working closely with R&D, engineering and manufacturing teams to resolve technical and compliance issues.