Current Vacancy:

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 julian.jones@isansys.com

NO AGENCIES PLEASE!

 

Regulatory Affairs Associate

Job Description

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.

Key Responsibilities

  • Technical File Generation.
  • Risk Evaluation and Assessment.
  • Support of clinical evaluations and Post Market surveillance.
  • Assist in the administration of the Change Management Process including proposing and implementing assigned changes.
  • Support all new software release activities.
  • Review technical standards and extract regulatory requirements for our products.
  • Support all Internal Audit activities.
  • Support external audit activities.
  • Complaints handling, monitoring and resolution.
  • Support internal investigations and CAPA.
  • Participate in project teams as required.

Key skills

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.