Quality Assurance Regulatory Affairs Manager

Quality Assurance & Regulatory Affairs | MedTech

Increase your chances of reaching the interview stage by reading the complete job description and applying promptly.
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 RoleManage 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 YouVascular/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 OpportunityTake ownership of RA/QA, work directly with leadership and help shape the quality and regulatory foundations of an evolving medical device business.
Interested? xzbcwsv Get in touch with for a confidential discussion.