Company Description

MedRAS is a trusted consultancy specializing in providing expert knowledge and advice to the medical device industry. Headquartered in Peterborough, United Kingdom, the company serves organizations nationwide and globally, offering training and consulting services to medical device companies of all sizes. MedRAS focuses on regulatory and quality affairs as well as project management, ensuring the successful progress of various medical device projects. With clients spanning across the UK, Europe, and beyond, MedRAS delivers professional solutions tailored to industry needs.

Role Description

This is a contract, remote role for an Associate Consultant at MedRAS. The Associate Consultant will support medical device organizations by providing expert advice on regulatory compliance and quality affairs. Responsibilities include conducting industry research, preparing and reviewing documentation, assisting with project management, and delivering training programs. The role involves liaising with clients to achieve their specific project objectives and ensuring regulatory alignment across various regions.

Experience and skills

Experience with MDD, MDR UKMDR and ISO 13485 is essential

Experience with MDSAP jurisdiction legislation and submissions is desirable

Experience in regulatory and quality affairs within the medical device industry
Strong analytical and research skills for interpreting regulations and standards
Project management skills with the ability to guide projects from inception to completion
Effective written and verbal communication skills to interact with clients and deliver training sessions
Exceptional organizational skills, attention to detail, and the ability to meet deadlines and deliver at pace

Qualifications

The associate will meet the criteria for PRRC as per article 15 of Regulation 2017/745