Medical Writing - Regulatory Associate

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 Medical Writing Specialist for regulatory documentation and support in CE/UKCA submissions for global MedTech clients. The role requires expertise in EU MDR, clinical evaluations, and ISO/QMS standards. You’ll collaborate across teams, support audits and training, and ensure compliance with evolving regulations. Ideal candidates will have 2–3 years of experience in regulatory affairs or medical writing within the medical device industry.

Role Responsibilities:

Regulatory Affairs:

·      Regulatory expert in preparing technical files and supporting projects for CE/ UKCA in Europe.

·      In house EUMDR expert in Clinical /medical writing providing support for the clients and leading client projects.

·      Experienced in preparation, review & approval of CER/CEP and lead the clinical and medical writing team. Acts as lead for assigned writing projects with in the MedTech excellence.

·      Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.

·      Very 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.

·      Set, communicate and train regulatory standards in the company in support of the Regulatory Compliance.

·      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 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.

Training:

·      Produce web-based training materials for Regulatory topics, write and develop user guides, documentation, and additional materials as required.

·      Prepare for and conduct in-person training sessions and produce custom web-based training for client-specific requirements including for all levels of the Regulatory knowledge.

·      Managing the strategy for the regulatory training arm of the organisation supporting the Training team. Oversee team training ensuring documentation and record keeping. Provide training to all employees as required.

Skills should include:

·      Relevant 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.

·      Education and Experience required as a Minimum:

·      Life sciences post graduate degree or equivalent.

·      2-3 Years of experience as medical writer, regulatory affairs , medical devices.

Why RegTrac?

We are dedicated to fostering growth and development, offering career progression, engaged and supportive management, specialized training, and a robust peer recognition and rewards program. Our self-culture empowers you to be authentic, with a strong focus on supporting and caring for our people. Together, we’re shaping the company we all aspire to be part of, and one our customers trust. By embracing diverse thoughts, backgrounds, cultures, and perspectives, we create a sense of belonging for everyone.