Senior Manager RA and QA

• Jan 2023 - Present

Consultant services for the Medical Device industry. SFL is a leading consultancy providing integrated solutions to pharma, biotech and medtech companies for global and local activities. SFL’s combined in-house expertise and services mirror key functions in a pharma or medtech product’s life cycle: Regulatory Affairs, Quality Assurance & GxP Compliance, Market Access & Reimbursement, Public Affairs & Regulatory Intelligence, Pharmacovigilance & Clinical Safety, Supply Chains of Medicines and Devices and Healthcare Compliance. Apart from strategic and operational support of client projects, experienced SFL team members can take over company-internal roles on an interim management base and provide training courses. As a Veristat company, SFL clients also have access to a substantial range of clinical development services such as global clinical operations, biostatistics and programming. Show less

Senior Product Specialist - Orthopaedic and Dental

• Jun 2022 - Jan 2023

Internally promoted.

Orthopaedic Product Specialist

• Sep 2018 - Jun 2022

- Authorised in the review of technical documentation for : * MD 0202/MDN 1102 - Non-active osteo- and orthopaedic implants * MD 0106/MDN 1208 - Non-active non-implantable instruments Class IIa/IIb/III medical devices- Involved in mentoring/supervising colleagues in MD 0106/MDN 1208 reviews

Interim Regulatory Manager

• Mar 2018 - Aug 2018

During a period of uncertainty, I lead the department, reporting into an offsite Director. With the change to the Regulations imminent, I took the decision to take a role at a Notified Body.

Senior Regulatory Engineer

• Jan 2017 - Aug 2018

Regulatory and Compliance Engineer

• Nov 2014 - Jan 2017

Involved in: - Regulatory submissions - Custom Devices - Annual Custom Device Reporting - Notified body liaison - Provide regulatory support to product development - Design examination certificate renewals - Traditional and Special 510(k) submissions - Internal Audit Program - KPI monitoring - CAPA and FSCA Involved in: - Regulatory submissions - Custom Devices - Annual Custom Device Reporting - Notified body liaison - Provide regulatory support to product development - Design examination certificate renewals - Traditional and Special 510(k) submissions - Internal Audit Program - KPI monitoring - CAPA and FSCA

Quality Engineer

• May 2013 - Nov 2014

A reorganization meant the R&D's development activities were absorbed by the Design Assurance group. The Quality Engineer role incorporates a large part of the previous NPD and Research role.Support operations providing directed quality engineering support Ensuring solutions are compliant, in the most efficient manner with ISO 13485 and FDA 21 CFR Part 820 Ensuring appropriate risk management documentation such as risk analysis, pFMEA and dFMEA are up-to-date and appropriate at all times Assist in the development process optimisation, measurement system analysis and formal process validation techniques Leading, facilitating and participating in formal problem solving to overcome production issues Supporting Non Conformance handling relating to production concerns As CAPA team member to perform corrective and preventive action (CAPA) activities Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of GDP and GMP DHF RemediationGeneration of 3D models using Computer Aided Design (CAD) Software (SolidWorks) and subsequent Engineering drawings. Show less

Research Scientist

• Mar 2010 - Apr 2013

Perform literature searches on new and current Orthobiologic technologiesAssess and recommend new technologies and companies for acquisition Involved in Voice of Customer, New Concepts and Unmet Needs analysisGenerate New Concept Prototypes Write Protocols to test New ConceptsManage several personal research projectsHave knowledge of Good Tissue Practice

New Product Development Assistant

• Nov 2009 - Mar 2010

Similar role to 3M, Medical Device, design and development, but in the Orthobiologics area. BSI trained in Medical Device Design Control (including FDA 21 CFR Part 820.30 QSR and BS EN ISO 13485:2003) Trained in Corrective And Preventative Action (CAPA) Investigations Attended an Intro and Intermediate Microsoft Project training course Participated and lead cross-functional project teams Performed research for Novel Orthobiologic Medical Devices Have related experience in Stability, Quality, Distribution, Packaging, Regulatory and Marketing areas to do with Product Development Helped produce documentation for BSI and FDA submissions Supervised a team of University Students working towards a Final Year Project Obtained a number of Company Recognition awards Show less

New Product Development Engineer

• Jul 2006 - Oct 2009

Designed and executed investigations and reported results back to project teams. Lead Developer on projects from feasibility through development to scale-up. Designed and supervised the "Design Verification Testing" process. Managed and assisted with laboratory QC including equipment calibration and maintenance. Kept laboratory clean and organised as Lab Supervisor. Have supervised a team of up to 6 colleagues. Fully trained and compliant in GcLP/GMP and COSHH. Frequently liaised with customers and suppliers. Have experience of purchasing high end lab equipment. Skilled in Method Development. Routinely performed statistical analysis on wide ranges of data. Proficient in Method and Equipment Validation. Maintain auditable records of components in and out of the department. Part of a project team that received a Technical Excellence award. Had poster presentations accepted for DDL 08 and RDD 09. Completed 3M's "Graduate Development Program". Completed LEAN Six Sigma Green Belt training. Show less