What are the responsibilities and job description for the Quality Assurance Regulatory Affairs Manager position at Established Search?
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.