Regulatory Affairs & Compliance Officer

Job Description

Bambi Medical is looking for an enthusiastic, determined person willing to work in a dynamic start-up environment. 

Regulatory Affairs & Compliance Officer will work on:

  •  Product compliance activities with the Medical Device Directive 93/42/EEC; Code of Federal  Regulations 21 CFR Part 820 and BS EN ISO     13485:2012 / 2016.
  •  Compliance and maintenance of technical files, design history files and regulatory submissions.
  •  Support of all compliance activities throughout the lifecycle of our product.

Key responsibilities

  •  Technical File Generation.
  •  Risk Evaluation and Assessment.
  •  Support of Clinical evaluations and Post Market surveillance.
  •  Review technical standards and extract regulatory requirements for products.
  •  Assist Change Management Process including proposing and implementing assigned changes.
  •  Complaints handling, monitoring and resolution. Support internal CAPA investigations.
  •  Support Internal & External Audit activities.

Key skills

  • Regulatory Affairs experience from a medical device  environment – At least 3 to 10 years experience in regulation of class I/ II medical devices

  •  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
  •  Excellent knowledge of MDD, ISO 13485 and ISO 14971
  •  Ability to work independently or as part of a group.
  •  Excellent written and oral communication skills of the English language are  a must.

If interested please send your CV and motivation letter to: