Sophie Orme

Regulatory and Quality Assurance consultant working within the medical device sector and across a multitude of projects.

As the company is a consultancy, the work varied and was dependent on the clients requirements, this included but was not limited to:
• Creation of Regulatory and Clinical Strategy,
• Quality Management System implementation and maintenance (including document control, SOP creation and update, and traceability),
• Clinical Evaluation (including conducting literature searches, data extraction, plan, protocol, and report creation),
• Post-market surveillance and vigilance activities
• Reviewing of relevant UK, EU, and USA updates and making internal updates to Regulatory intelligence,
• Ensuring Regulatory compliance with reference to relevant standards,
• Project management including use of project management tools such as Monday.com

• Independently working on projects, as well as collaborating with internal and external teams on multidisciplinary team projects.
• Supporting with BSI audit preparation and process.

• Managed infrastructure and storage systems such as, Avamar and Vsphere, to ensure valuable data was consistently stored and backed up.
• Ensured all data was stored inline with GDPR and data protection laws.
• High level of proficiency in IT including, Microsoft office suites, and administrative duties within a variety of software environments.
• Worked effectively and efficiently to timeframes, including project and upgrade deadlines.