Regulatory Affairs Associate
2 weeks ago
This will be part of a growing Quality and regulatory department and is a varied role which requires working with Clinical, R&D, Development, marketing and technical support colleagues to ensure regulatory compliance through the entire product lifecycle.
**Requirements**:
**Key responsibilities**:
- To support Brainomix’s compliance with the applicable regulations in the UK, EU, US and other regions as required
- To develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.
- To prepare high quality device registrations for approval by the competent authorities in the US, EU/UK and other markets as required
- To maintain records on legislation, standards and guidelines.
- To maintain and to develop product technical files in compliance with regulatory requirements
- To investigate regulatory history of similar products to assess approval implications
- To work closely with other teams in the areas of Vigilance and Post Market Surveillance
- To support the progress of New Product Development, Renewal and Re-Authorisation submissions
- To participate in Continuous Improvement Initiatives to further develop department functions
**Required Experience**:
- 2+ years’ experience in Quality and/or Regulatory roles within Medical Devices
- Ability to summarise and explain technical and scientific information for communication internally and with external parties
- Time management skills, writing, coordination, and execution of basic regulatory items
- Ability to work to tight deadlines and on own initiative in a fast-paced environment and rapidly evolving and expanding project plans
- Ability to communicate and work with people both inside and outside the department
**Desired Knowledge and Skills**:
- Experience with EU MDR and/or US FDA regulatory requirements
- Experience of writing, collating, and submitting technical files for CE certification and/or US FDA submission
- Experience with medical device incorporating software and/or SaMD
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