Quality Assurance Regulatory Affairs Manager

Established Search Ltd; Miami (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Established Search Ltd in Miami seeks a regulatory affairs and quality assurance professional to take ownership of the RA/QA function. You will manage the QMS, ensure compliance with ISO 13485 and medical device regulations, and support regulatory submissions and technical documentation.

You will collaborate with R&D and engineering teams to ensure products meet regulatory and quality requirements, while supporting development, testing, validation and manufacturing transfer as the company scales.

Qualifications

• Experience in Regulatory Affairs, Quality Assurance or RA/QA in MedTech.
• Knowledge of ISO 13485 and relevant medical device regulations.
• Experience with QMS processes, audits, risk management and CAPAs.
• Understanding of regulatory submissions and product documentation.
• A hands-on approach, comfortable working independently in a growing business.

Responsibilities

• Manage and maintain the quality management system (QMS).
• Ensure compliance with medical device regulations and ISO 13485.
• Support regulatory submissions, product approvals and documentation.
• Oversee audits, CAPAs, risk management and quality documentation.
• Collaborate with R&D and engineering to meet regulatory and quality requirements.
• Support product development, testing, validation, and manufacturing transfer.
• Build practical quality and regulatory processes to support growth.

Skills

RA/QA in MedTech

ISO 13485

QMS

Audits

CAPAs

Risk management

Regulatory submissions

Job description

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

• 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.