Charlie Parker

A highly dedicated professional with extensive international experience in bio-analytical diagnostic systems, with 14 years of expertise in ISO13485 Design Control for IVDs. My credentials include PRINCE2 project management practitioner certification, a Lean Six Sigma Black Belt and ISO13485 internal auditor. As a proven cross-functional team leader, I have successfully executed business-critical projects, enabling products to reach the markets of IVDR (Class C&D), WHO ERPD, MDSAP, and the Chinese FDA.

Adept at analytical and risk based problem-solving, I am driven to develop highly profitable products with a focus on end-user experience and patient safety. Passionate about training, I excel in embedding efficient processes and upskilling staff to ensure team success.

IVD Consultant

CP Consultants Ltd 2022-Present

From small university spin out start-up companies to multinational organisations, I have been supporting cross functional teams to meet today’s regulatory requirements for IVDR & WHO with focus on the migration of products from R&D to Design Verification & Validation. In order to keep abreast of new standards as well as giving back to the scientific community, I am a ISO standards maker representing the UK in BSI committees and document reviewer for CLSI.

Previous / current assignments deliverables;

• Updating and embedding Design and Development practices for the client.
• Design and development plans (& project plans), Design Inputs, Design Reviews,

Performance Evaluation Plans, Analytical Performance Reports, Performance

Evaluations Reports.

• Analytical Performance SOPs, Stability SOPs, Protocols and Reports against CLSI and ISO. Delivery of training workshops to client’s staff and academic institutions.
• Taking the lead for the creation of product FMEAs (Design, User & Process).
• Scientific Validity Report & State of the Art reports, including training sessions.
• Performed gap analysis against existing Design and Development documentation and instigated remediation plans.
• QC method validation SOP (Test Method Validation), Validation Master Plans,

Protocols and Reports including training sessions.

• Computer System Validation assessments, protocols and reports for manufacturing equipment.
• Usability training workshops.

Portfolio of products include

• Developing new molecular tests for point of care sexually transmitted disease detection using novel sequence targets.
• Developing laboratory based molecular tests for women’s cancer.
• Transition from IVDD to IVDR for class C and D Blood Grouping devices.
• Supporting point of care products from Concept to Design Verification for infectious diseases.

HEAD OF R&D / R&D MANAGER

Omega Diagnostics / 2015-2022

An active member of the site senior management team and reporting directly to the CEO, whilst leading the development, implementation and delivery of the company’s group R&D strategy for IVD products under ISO 13485.

• Delivered from concept to development, verification, validation and technical transfer of OEM product which met Chinese FDA standards for self-test product.
• The company’s chief technical authority and subject matter expert for change control, NC and CAPAs.
• Revised the entire company’s design process which has been demonstrated to be compliant to ISO13485 and MDSAP requirements in readiness for IVDR.
• Experienced in design activities such as; generating design inputs, establishing and managing traceability matrix and DHF, verification activities, leading design reviews, directing transfer activities out of development, supporting sales and regulatory departments with post market activities.
• Key member of company’s risk assessments team under ISO 14971 for writing risk management plans, performing preliminary hazard analysis and FMEAs

PhD

Analytical Biochemistry

Cranfield University