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.
- 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.
- 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