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Regulatory Affairs Specialist
Sutton (Full Time, Permanent)
£40,000 - £45,000 / Year
Regulatory Affairs Specialist - Sutton, Greater London
Melbreck Technical are working with a leading Designer and manufacturer of Medical Devices and Specialist Medical Equipment based in South London.

Due to several new projects and products now coming to fruition they are looking for a regulatory affairs specialist to join their business on a full time basis.

Working closely with the quality assurance and design teams you will have good knowledge of worldwide regulatory standards and demonstrable experience of ISO13485, CE marking, technical file submissions and of driving regulatory processes and activities.

There will be an initial focus on providing a gap analysis against the clients current product portfolio and developing remediation plans to meet current medical device requirements.

Education/ Qualifications Required:

A BSc or MSc degree within an engineering, design, medical or sciences background or equivalent experience

Skills/ Experience Required:

Demonstrated Regulatory experience in active Class IIb and III medical devices
Experience dealing directly with Notified Bodies, Competent Authorities and MHRA
Hands on experience of creating compliance documentation
Knowledge of compliance with key international standards such as ISO 13485, ISO 14971
Excellent communication skills
Strong organisational skills, including the ability to prioritise workload
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial

If this role is of interest then please get in contact ASAP and Quote the following reference #2168