Associate Consultant
Posted Today by MedRAS
Negotiable
Undetermined
Remote
Peterborough, England, United Kingdom
Summary: The Associate Consultant role at MedRAS is a remote contract position focused on providing expert advice to medical device organizations regarding regulatory compliance and quality affairs. The consultant will conduct industry research, prepare documentation, assist with project management, and deliver training programs to ensure clients meet their project objectives. This position requires strong analytical skills and effective communication to liaise with clients and ensure regulatory alignment. Experience in the medical device industry, particularly with relevant regulations, is essential for success in this role.
Key Responsibilities:
- Conduct industry research to support medical device organizations.
- Prepare and review documentation related to regulatory compliance.
- Assist with project management to guide projects from inception to completion.
- Deliver training programs to clients on regulatory and quality affairs.
- Liaise with clients to achieve specific project objectives.
- Ensure regulatory alignment across various regions.
Key Skills:
- Experience with MDD, MDR UKMDR, and ISO 13485.
- Desirable experience with MDSAP jurisdiction legislation and submissions.
- Experience in regulatory and quality affairs within the medical device industry.
- Strong analytical and research skills for interpreting regulations and standards.
- Project management skills.
- Effective written and verbal communication skills.
- Exceptional organizational skills and attention to detail.
Salary (Rate): undetermined
City: Peterborough
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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