Healthcare providers, insurers,
system integrators, clinicians
and clinical investigators
Regulatory Affairs Associate
£30,000 - £35,000 per annum
Job type: Permanent, full-time
Date: 21st October 2015
To apply for this role please send a current CV and cover letter to firstname.lastname@example.org
NO AGENCIES PLEASE!
To support the regulatory affairs function within Isansys Lifecare Ltd and to assist with the compliance of activities and products with the Medical Device Directive 93/42/EEC; Code of Federal Regulations 21 CFR Part 820; BS EN ISO 13485:2012. To compile and maintain technical files, design history files and regulatory submissions. To support all compliance activities throughout the lifecycle of our products.
Degree level in engineering or appropriate academic discipline.
No less than 3 years' experience in regulation of class II/III medical devices.
Excellent knowledge of MDD, ISO 13485 and ISO 14971
Strong attention to detail.
Ability to work independently or as part of a group.
Preferably good knowledge of one or more of the following:
BS EN 62304 Medical device software — Software life-cycle processes
BS EN 60601 Medical electrical equipment — General requirements for basic safety and essential performance
BS EN 62366 Application of usability engineering to medical devices
To be considered for this role it is essential that you have previous Regulatory Affairs experience from a medical devices environment. Excellent written and oral communication skills are a must.