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:

·      Author review and approved relevant procedures as applicable as per the required QMS system.

·      Monitor Quality processes and procedures required to ensure the applicable standard is achieved, including approved QMS.

·      Provide internal stakeholders a guidance and recommendations in the application of all relevant Industry Standards and Regulations.

·      Monitor customer/supplier quality and provide rapid response for quality problems from regulatory requirements.

·      Provide support to oversee all Audits, external and internal inspections, and their reporting, ensuring compliance and conduct supplier/customer audits where required in collaboration with QA team.

Qualifications:

·      Advanced degree (Master’s or PhD) in a relevant field.

·      5 years of experience in Quality, Regulatory affairs or governance in a structured environment.

·      Have excellent written and oral communications skills to communicate clearly and effectively with third parties, regulatory authorities and management.

·      Inquisitive, self-motivated and focused.

·      Self-Starter, Keen to learn, Ability to plan, good organisational skills and work in a team.

·      Proven strengths in attention to detail, analytical ability, understanding and interpreting regulations.

·      Looking for a company where they may broaden their experience and grow with the company.

·      You will be process driven with a can-do approach to find fitting and effective solutions to move projects forward.

Why Join RegTrac?

RegTrac