REGULATORY AFFAIRS & COMPLIANCE OFFICER

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.
  • Supporting 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.
  •  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 devices 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

o   BS EN 62304 Medical device software - Software life-cycle processes

o   BS EN 60601 Medical electrical equipment - General requirements for basic safety and essential performance

o   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 English are a must.

 

If interested please send your CV and motivation letter to: Claudia@bambi-medical.com