Quality Assurance Regulatory Affairs Manager

Quality Assurance & Regulatory Affairs | MedTech

I've partnered with a growing medical device business looking to strengthen its Regulatory Affairs and Quality Assurance function.

This is an opportunity to take ownership of regulatory compliance and quality processes, working closely with R&D, engineering and senior leadership to support product development and future commercial growth.

The Role

• Manage and maintain the company's Quality Management System (QMS).


• Ensure compliance with relevant medical device regulations and ISO 13485.


• Support regulatory submissions, product approvals and technical documentation.


• Oversee audits, CAPAs, risk management and quality documentation.


• Work with R&D and engineering to ensure products meet regulatory and quality requirements.


• Support product development, testing, validation and manufacturing transfer.


• Build practical quality and regulatory processes to support the company's next stage of growth.

About You

• Vascular/cardio/neuro/endovascular experience required.


• Experience in Regulatory Affairs, Quality Assurance or a combined RA/QA role within MedTech.


• Knowledge of ISO 13485 and relevant medical device regulations.


• Experience with QMS processes, audits, risk management and CAPAs.


• An understanding of regulatory submissions and product documentation.


• A hands-on approach, comfortable working independently in a growing business.

The Opportunity

Take ownership of RA/QA, work directly with leadership and help shape the quality and regulatory foundations of an evolving medical device business.

Interested? Get in touch with daniel.farag@established-search.com for a confidential discussion.