Saskia Berkin Email & Phone Number

London, England, United Kingdom

Smart Surgical Solutions (S3) is a MedTech spinout company from Imperial College London, developing the next generation of orthopaedic surgical navigation tools.- Build and implement the quality management system and relevant processes for the business, in accordance with regulatory requirements (ISO 13485, 21CFRs)- Conduct internal audits and maintain documentation to ensure compliance with quality standards- Prepare and submit regulatory submissions and documentation to obtain and maintain product approvals- Collaborate with cross-functional teams, regulatory consultant and the team at Imperial College to support product development, design control, and risk management activities

Founded an Arts Education Business.

Hull, United Kingdom

- Plan and execute R&D/Quality activities to support the remediation of the business product portfolio relative to the European Medical Device Regulations (MDR)- Co-ordinate with relevant global, regional and local teams, including external manufacturers to ensure adequate implementation, communication and training of the new business processes-Maintaining relationships with external supplier key contacts globally to ensure smooth roll out of product remediation activities within manufacturing and supply chain operations

Kingston Upon Hull, England Metropolitan Area

- Identify operational improvements by collecting information, and generating insights and recommendations, including establishing new processes for future NPD project initiation taking into account the increased evidence, scrutiny and costs of gaining product registration under MDR legislation- Update existing R&D/Quality processes for the generation of product technical documentation

Hull

- Managing a portfolio of external manufacturing change control projects driven by imperatives including cost saving, compliance and enforced material changes- Leading cross-functional project teams including global third party manufacturers (EU/US/China)- Compiling and reviewing technical documentation, ensuring work was compliant with the relevant policies and regulations- Overseeing process validation and process verification within manufacturing- Performing all activities in compliance with relevant GMP and quality systems standards, specifically with FDA quality system regulations and with ISO 13485- Co-ordinate with commercial and procurement teams to develop new supplier partnerships for the business

- Co-ordinate with relevant global, regional and local teams to ensure adequate implementation of commercial projects- Conducting performance and analysis evaluations of competitor products- Delivering projects in accordance with agreed KPIs and benchmarks- Contributing to the continuous improvement of the analytical function with respect to new analytical technologies, procedures and processes

Harrogate

- Operational support to the bioanalytics department including performing assays, assay transfers, validations, samples analysis, batch/release testing, and stability studies- Conducting all work in compliance with the applicable regulatory requirements (GLP/GCP/GMP) specified in the study plans, protocols, or client work agreements

Hull, United Kingdom

- Working with regional and global consumer insights & marketing teams to validate new ideas into the commercial pipeline- New product development including laboratory technical testing, validation, industrial trials and dossier preparation

Bachelor Of Science (Bsc), Biochemistry

Education record