Senior Regulatory Affairs Associate - Medical Devices

Company Overview

RegTrac is a leading healthcare regulatory partner specializing in Global Regulatory Affairs, Quality Systems, and Compliance for Medical Devices, Cosmetics, and Consumer Products. With expertise in navigating regulatory requirements across diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success.

Role Description :

We are seeking a highly motivated Senior Regulatory Affairs Associate who will lead and support regulatory projects across global markets, with a focus on Clinical Documentation – Clinical Evaluation & Investigations for CE / UKCA, EU MDR compliance, and medical device documentation. In this role, you will be managing client relationships, preparing regulatory submissions, and ensuring adherence to ISO and QMS standards. You will collaborate cross-functionally, support audits, and contribute to solution development for new business. Ideal for a proactive, detail-oriented professional seeking to grow in a dynamic regulatory consulting environment.

Key Responsibilities :

Regulatory Affairs :

• Regulatory experience in preparing CER / CEP, technical files and supporting projects for CE / UKCA in Europe.
• EUMDR experience providing support for the clients and leading client projects.
• Good knowledge of medical device labelling and understanding of review & approvals for medical device labels.
• Good knowledge of ISO standards / Industry compliance regulatory standards like ISO 13485 / 10993 / 14971.
• Support & resolve regulatory document related queries from manufacturers and provide solutions.
• Provide support for sales and solutioning in completing requirement analysis for leads in winning projects.
• Ensure client projects are performed and documentation prepared, reviewed and approved in line with relevant legislation requirements and guidance, meeting any specific requests or methodologies following the system and procedures in place.
• Manage and build on client relationship's ensuring feedback sessions are completed on a regular basis.
• Be up to date with changing regulatory requirements and guidelines and update the company with these changes.
• Prepare solutions, proposals and estimate the required effort hours in support of sales team including supporting sales presentations.
• Ability to manage projects, teams and work cross-departmentally to gather project-specific requirements, information, and needs.
• Foster a dynamic working relationship with RegTrac Clients.

RA-QMS :

Qualifications :

Why Join RegTrac

At RegTrac , you'll join a collaborative, supportive team that values expertise, curiosity, and purpose. The company fosters a culture of continuous learning, where your voice matters and your growth is actively supported through mentorship, diverse global projects, and real responsibility. You'll be part of a close-knit community passionate about regulatory science and improving healthcare outcomes, with the flexibility to work remotely and balance life outside of work. At RegTrac, it's not just about compliance—it's about making a meaningful impact together, in a place where people genuinely enjoy what they do and who they do it with.

Skills Required

Knowledge of medical device labelling, EUMDR experience, Regulatory experience in preparing CER CEP technical files