Peter Ratcliffe, Phd Email & Phone Number

United Kingdom

Sheffield, England, United Kingdom

Short term contract with priority to reshape MDR strategy, mentor and coach senior management and cross-functional teams.• Acting as PRRC.• Managed international registrations.• Review of Technical Documentation, CERs, SSCPs and PSURs.• Led the Notified Body response strategies.• Maintenance/updating of procedures.• Complaint management.

Acting as a leading consultant: • Led the response effort for Notified Body EU MDR questions for a large global spinal implant company, working with cross-functional teams, drafting responses and providing strategies.• Performed gap analyses on Design Control documentation and labeling, created new user requirements and design input documents, and supported updates to the risk analysis for a large global blood glucose monitoring system manufacturer in preparation for the EU IVDR submission.

Swindon, United Kingdom

Defined corporate RA strategies, policies and procedures, acting as a RA SME for the MDR/IVDR implementation. Led the corporate RA Brexit strategies, providing direction on the product registration/UK RP activities and training and planning for the UKCA marking.• Represented company at Medtech Europe and ABHI industry working groups.• Led multiple MDR implementation workshops and acted as corporate MDR Training and Communications Lead.• Led the corporate Brexit Notified Body transfers, interim measures and MHRA consultation process. • Selected as a pilot site by the MHRA, completed MHRA re-registration of Biomet portfolio (acting as EC REP).• Supported UK site initiatives such as GTS (distribution control) rollout and the NHS eProcurement implementation.• Updated UK labels to include a GS1 UDI data matrix barcode.

Swindon, United Kingdom

Created a new EMEA registration organisation and processes, acting as a focal point for Biomet affiliates and distributors for the RECON and SET business units.• Biomet EMEA regulatory intelligence lead.• Managed the UK label and IFU processes.• Improved communication and co-ordination of EMEA registrations across the Biomet business.• Led the EMEA registration data gathering for GTS and the Zimmer Biomet integration.• Provided EEA-CH registration data for the Discovery elbow divesture to Lima.• Managed various re-registration projects for Russia and Turkey for the Biomet portfolio.

Swindon, United Kingdom

Managed the RA teams in UK, France and Spain for CE marking and EMEA registrations for hip, knee, trauma, spine and extremity products (classes I to III).• Interacted and worked with the Notified Bodies, Competent Authorities and country regulatory contacts to resolve issues arising during the regulatory submission review process to ensure timely approval or post market surveillance.• Responsible for the Design Control Quality Assurance of the UK Design History Files (DHFs).• Managed the UK label and IFU processes.• Deputy Designated Individual required for the release of Human Tissue products.• Acted as EU Authorized Representative for Biomet US based legal manufacturers.• Developed consistency with Technical File and Dossier templates across different legal manufacturers.• Developed the UK Design Examination Certificate Renewal strategy ensuring 100% renewal success.• Change Review Board member.

Managed the RA team across both Biomet UK sites for CE marking and EMEA registrations for hip, knee, trauma and extremity products (classes I to III).• Interacted and worked with the Notified Bodies, Competent Authorities and country regulatory contacts to resolve issues arising during the regulatory submission review process to ensure timely approval or post market surveillance. • Responsible for the Design Control Quality Assurance of the UK Design History Files (DHFs).• Managed the UK label and IFU processes.• Acted as EU Authorized Representative for Biomet US based legal manufacturers.• Following Kaizens, introduced revised IFU generation and label review processes.• Instigated a European wide approach for regulatory release of product. • Initiated a Technical File remediation plan to meet the latest revision of the MDD (M5 changes).• Coached development engineers in Design Control and Risk Management (ISO 14971).• Appointed as a Change Review Board member.

Provided regulatory strategy to project teams, communicating with the Competent Authorities and Notified Bodies, compiling Technical Files, approving labeling, obtaining the necessary legalized documents for country specific registrations and authorizing approval for shipments (AFS).• Completed regulatory activities for two major projects.• Led the UK recommendations as part of the major overhaul of the AFS process.• Site Leadership Team Award for outstanding contribution for RA departmental performance.

Led a team to investigate non-conformance events using a range of quality tools, in order to identify and implement effective corrective actions (CAPAs).• Coached team to meet corporate non-conformance rubric report writing standards and satisfy approval through the Quality Review Board.• Exceeded divisional goals by reducing number of open non-conformance events to zero in 2008.• Maintained role as key Technical expert on Quality Review Board to assess non-conformances.• AQR GQMS CAPA Rubric Approver Certification.• Facilitated Green Belt Kaizen project.

As Project Manager for NPI (in vitro diagnostic device) and business change projects successfully managed cross-functional UK/USA Technical, Quality, Operations and Marketing teams.Achievements include:•Received two Vice-Presidents Awards for outstanding contributions for the introduction of a new hospital blood glucose monitoring system and for the transfer of the G2b strip manufacture from Abingdon to Witney (ensuring continuity of supply and compliance to the FDA Design Control Regulations).•As part of establishing a new PMO, developed the training programme with external consultant trainer resulting in over 80 people trained in the PMI PMBOK project management methodology.•Obtained Lean Six Sigma Green Belt certification following the successful completion of Kaizen (process improvement) and Design for Lean Sigma projects.•Received Vice-Presidents Award for outstanding contribution for completing a special 6 month assignment as a key Technical expert on Quality Review Board to assess non-conformances, for both the UK and USA manufacturing organisations during 2007 prior to successful FDA and corporate site audits.

As Project Manager, responsible for a business critical second sourcing material project for an existing on-market product.Achievements include:•Successfully implemented project three months early, thereby saving ~£110K and the conservation of existing surfactant for other products.•New test method developed for both internal and supplier quality control, enabling cost savings for all parties. •Received Vice-Presidents Award for outstanding contribution.•Managed the successful introduction of a new cross-functional Material Support and Selection Process.•Maintained role as key Technical expert on Quality Review Board to assess non-conformances.

Phd, Chemistry, Pass

Activities and Societies: Chemical Society Treasurer, Hatfield College hockey PhD: Plasma Assisted Deposition of Thin Films.

Bsc (Hons), Chemistry, Upper Second Class

Activities and Societies: Hatfield College rowing and hockey clubs, Industrial Society

A-Levels: Chemistry, Physics And Maths, A, A, B

Activities and Societies: Represented school for rugby, hockey and cricket. School prefect and Head of House