Dr Ari Raju

• IVDD, IVDR, MDD, MDR, ISO 13485, 21 CFR 820, 510K, MDSAP, OTHER COUNTRIES REGISTRATION FOR IVD AND MD)
• IVD/CDX
• Pharma CTS/Clinical Trials - Devices/IVD
• Directed complex projects to successful completion.

Quality/Regulatory/Technical requirements for client product by streamlining by implementing required processes.

• Developed effective business strategies for sustained growth.
• Promoted a culture of continuous improvement, driving operational excellence.
• Built a harmonious work environment with strong leadership skills.
• Directed day-to-day work of SME's/ Team Members and motivated teams to exceed objectives.
• Worked with board of directors to establish objectives and decisively lead operations.
• Allocated resources to teams and projects based on need, performance and availability.
• Established budgets based on historical, current and forecasted business data.
• Advanced training programmes, boosted employee skills and performance levels.
• Streamlined processes, achieved better resource allocation.

• Clinical Trial Studies - Gap analysis (Contract)
• Clinical Trial Studies (CTS) - IVD and MD - Regulatory compliance requirements as per UK, EU and USA gap analysis
• Gap analysis - Vendor's/Sub contractors MD and IVD regulatory compliance requirements and remediation actions
• Gap analysis current CTS process and provide remediation/effective improvement
• IVDD to IVDR regulatory gap analysis - CTS
• MDD to MDR regulatory gap analysis - CTS
• Collaborated with a variety of industry professionals for effective project delivery.

• Health care product manufacturer - Regulatory Consultant - Global Regulatory Germany (, Clinical assay trial (CTA) / Companion Diagnostic clinical performance (CDx) - Combination and companion Diagnostic regulatory support and implementation
• Gap analysis IVDR/MDR Devices/IVD products and remediation
• Gap analysis and remediation IVDR - Health Institutional requirements
• Regulatory support - GMP auditing
• Regulatory support - international clinical trials
• Medical Devices Software IEC62304 lifecycle process for CTA- Gap analysis and remediation
• Carried out day-to-day duties accurately and efficiently.

• Developed the regulatory strategies for life cycle management and expansion of manufacturing of NGS reagents, software and Algorithm - AI products
• Preparation of the registration packages and responses to deficiency letters
• Effective communication with regulators to negotiate the requirements of the submitted data and delivery times
• Be the primary contact during quality and regulatory inspections and be responsible for managing escalated customer issues and driving continuous improvement activities
• Developed and implemented a clear customer-centric vision for quality and regulation
• Manage, coach, and communicate the vision to internal and external leaders across the organization
• Ensure assessment of changes in manufacturing for regulatory effects and compliance with applicable regulations
• Awareness of global regulatory requirements
• Carrying out the necessary tasks of personnel management and supporting management
• Conduct due diligence to support the further development of the corporate strategy
• Managed the budget and cut costs by implementing an effective QMS process (save 0.5 million per year)
• Managed team of 25 (Quality and Regulatory)
• Collaborating BioPharma - clinical trial - Companion diagnostic
• Enforced compliance standards for regulatory adherence.
• Established partnerships for expansion opportunities.
• Maintained high staff morale through effective leadership techniques.
• Oversaw financial operations to ensure fiscal stability of the organisation.
• Directed resources to maximise productivity levels.
• Streamlined operations by implementing efficient management strategies.
• Fostered a positive work environment with open communication channels.
• Mitigated risks, enhancing overall operational efficiency.
• Led team for successful project outcomes.
• Coordinated cross-functional teams for streamlined workflow processes.
• Worked with board of directors to establish objectives and decisively lead operations.
• Established budgets based on historical, current and forecasted business data.
• Partnered with management team to optimise operations and reduce costs.

IVDR Gap analysis, Remediation and Implementation process.

• Client - BioAgilytix Lab (USA) - IVD Companion Diagnostic products (CDx) Creation of Regulatory Strategy for US and EU registration
• Regulatory support for Intended Use, Classification, Confirmatory Assessment routes, CTA process/CDx - Phase I for US and EU market - completed
• Phase II - Gap, remediation and CE/PMA approval
• Successfully delivered on tasks within tight deadlines.
• Performed gap analysis, identifying areas of underperformance and inefficiency.
• Facilitated skills gap analysis, resulting in targeted training initiatives.
• Identified process inefficiencies through gap analysis.

• IVDR training - 14 modules for around 10 people
• IVDR gap analysis strategy
• IVDR / Design development strategy
• Ad hoc projects - IVD design, regulatory, performance etc
• Ensured compliance with industry standards in all training activities.
• Liaised closely with department heads for relevant course content creation.
• Adapted teaching methods based on learner profiles, increasing knowledge retention rates.
• Identified skills gaps for targeted training interventions.
• Collaborated with Subject Matter Experts (SME)s to refine and update training resources.
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• IVDR implementation for MDx and CDx for fully automated molecular diagnostic devices (oncology and infectious diseases).
• Regulatory lead – Successful achievement of CE marking for GeneFusion (IVDD 98/79/EC)
• Successful implementation of IVDR Performance Evaluation as per annex XIII and integrated with current design control process (verification and validation)
• Successfully completed CDx BRAF technical file to the notified body (BSI)
• Lead Regulatory for IVDR QMS audit by BSI and successful achievement with No non-conformance and no observation

• During COVID pandemic situation I lead the Department of Health and Social Care (DHSC)/ UK Health Security Agency (UKHSA) as Head of Clinical Performance COVID Test and Trace (IVD) United Kingdom project.
• Lead Clinical performance area for COVID UKHSA/DHSC test and trace LFT, real time PCR Test kit and sample collection kit for RT PCR/LAMP test.
• Coordinate the implementation and assessment of IVD devices performance.
• Collaborate with Quality team and support implementation of Quality system as per ISO 13485 and ISO 15189
• Regulatory lead for the selection and approval of new IVD self-tests for COVID.
• Implementing clinical evidence process as per IVDR.
• Acted as regulatory SME for the approval of new vendor selection and approval for COVID test kids.
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• Clinical evidence collaboration between MHRA/UKSHA.

• Client - Qiagen - Creation and Implementation of PEP/PER for Qiagen products as per IVDR.
• Collaborated with a variety of industry professionals for effective project delivery.
• Strengthened stakeholder relationships through effective communication and engagement methods.

• Managed budgets diligently, controlled unnecessary expenditure on projects.
• Mitigated potential risks effectively, safeguarded against possible pitfalls within projects.
• Streamlined processes using lean methodologies, improved operational efficiency significantly.
• Ensured effective resource allocation with meticulous project scheduling.
• Fostered a positive work environment, enhanced team productivity substantially.
• Guided the development of project objectives, established clear performance expectations.
• Promoted team collaboration for more innovative solutions in projects.
• Developed comprehensive project plans for successful execution and delivery.
• Led cross-functional teams to achieve project goals on time.
• Implemented quality control measures, ensured adherence to standards.
• Identified risks, implemented mitigation strategies for secure project outcomes.
• Planned staff and resources within business budgets for minimized expenditure.
• Delivered products and services in line with agreed arrangements and contracts.
• Negotiated contract terms for maximized client benefit and profit.

Major Deliverables

• Lead and Manage Quality and Regulatory teams and cross functional SME's (R&D, QC, Purchasing, manufacturing, Sales, legal, Cyber Security, HR etc) (Teams from 5 to 15)
• IVDR gap analysis – Annex I, Annex II, Annex III, Annex XIII and Article 10.
• IVDR Technical File creation and implementation .
• IVDR Article 10 QMS implementation,
• IVDR Implementation - Annex I GSPR, Annex II TF, XIII PEP, PER, APR, CPR, SVR, PMPFR, Annex III – PMSP, PMPFP, PMSR, PSUR
• IVDR Summary and Safety Performance (SSP) Implementation
• IVDR Clinical Evolution – provide technical support with current APR and CPR performance data as per CLSI/EPA and other regulatory requirements.
• IVDR/CDx clinical performance (co development and follow on) support as per Annex XVI – Interventional Clinical Performance studies and certain other performance studies (Article 56 to 77)

· Implementing all other IVDR requirements including- Article 14 – Distributor requirements, Article 5 (testing lab), Creation of actor registration - SRN (EUDAMED), UDI, Article 15 PRRC, Article 16 Importers, Distributor and others, etc.

· Supporting Notified body application process

· IVDR internal audit and Training

· Supporting and Lead IVDR QMS as well as technical file Notified Body audits .

Clients:

A. Agendia Precision Oncology – USA – IVDR gap analysis and implementation – Class C device

• B. Perkin Elmer USA – IVDR Gap analysis and proposed for Phase 2 implementation

C. Statlab – USA – IVDR Gap analysis

D. Statlab USA – IVDR implementation – Class A device

E. Harvard/Biochrom UK/USA– IVDR Gap analysis

F. Harvard/Biochrom UK/USA – IVDR implementation – Class A device

• CRO - IVD Regulation Guide book reviewer - United Kingdom (Contract) Completed
• Reviewer - Handbook - Practical Guide to Implementation of EU IVDR
• Reviewed and edited written material, ensuring accuracy and consistency.
• Identified critical issues with thorough analysis of data.

• Implemented and co- ordinated different stakeholder for COVID product development from Design and Development to Manufacturing.
• Coordinated and implemented all performance procedure as per CLSI and MHRA TTP for COVID diagnostic device.
• Coordinated and Implemented all QMS process/process as per ISO 13485 2016 and 21 CFR 820.
• Implemented and coordinated clinical performance with Arizona State University (ASU) for COVID diagnostic clinical studies.
• Successfully achieved CE marking for Lamb based COVID Kit.
• Successfully achieved ISO 13485 certification
• Liaised closely with clients throughout consulting process, ensuring satisfaction at every stage.
• Provided expert advice on organisational change, resulting in streamlined QA/RA operations.

• Implemented and co- ordinated different stakeholder for COVID NGS product development from Design and Development to Manufacturing.
• Coordinated and implemented all performance procedure as per CLSI and MHRA TTP for COVID diagnostic device.
• Coordinated and Implemented all QMS process/process as per ISO 13485.
• Successfully implemented CE marking for NGS based COVID Kit.
• Successfully achieved ISO 13485 certification
• Liaised closely with clients throughout consulting process, ensuring satisfaction at every stage.
• Provided expert advice on organisational change, resulting in streamlined QA/RA operations.

• Lead and collaborate with 15 team members in NAMSA
• Collaborate with different SME's from Simens (R&D, Quality, Regulatory) for successful implementation of legacy IVDD products into IVDR transition
• IVDR Implementation - Annex I GSPR, Annex II TF, XIII PEP, PER, APR, CPR, SVR, PMPFR, Annex III - PMSP, PMPFP, PMSR, PSUR
• IVDR Summary and Safety Performance (SSP) Implementation
• IVDR Clinical Evolution - provide technical support with current APR and CPR performance data as per CLSI/EPA and other regulatory requirements
• IVDR clinical performance support as per Annex XIII - (Article 56 to 77)
• Successful completion of 15 class C and B technical files.

• Coordinate all IVD business activities in the UK, including certification and notification queries
• Carried out day-to-day duties accurately and efficiently all IVD related projects.
• Successfully delivered on tasks within tight deadlines.
• Demonstrated respect, friendliness and willingness to help wherever needed.
• Increased customer satisfaction by resolving issues.
• Implementing certification and notification requirements in UK business site
• Initiate of IVDR implementation and collaboration
• CDx process implementation.
• Oversaw daily operations to achieve high productivity levels.

• Client: Ortho Clinical Diagnostic (UK/USA) - IVDD-IVDR remediation
• Recruit and lead team (15 members) for IVDR implementation process (India)
• Successful implementation of gap analysis and implementation of the IVDD-IVDR technical file (Annex I, II and III)
• Designed comprehensive risk mitigation plans, ensuring project stability.
• Liaised with stakeholders to understand expectations and needs better; ensured customer satisfaction in service delivery.
• Enhanced performance metrics by establishing key performance indicators.
• Established clear lines of communication amongst team members; improved collaboration efforts.
• Managed multi-disciplinary teams to ensure programmed delivery on time.
• Successful completion of IVDR for 20 products (Class A, B and C).
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• Group Regulatory Compliance Manager (Oct 2017–AAug 2018) is responsible for five sites: Paris (Novacyt), Cambridge (Lab21), Camberley (Microgen), Southampton (Primer Design), and Bridport (Lab21 Healthcare—Plasmatec and Biotec).
• Senior QA/RA Manager (Jan 2017–Oct 2017)—NOVACYT GROUP (Microgen Bioproducts, Lab21 Healthcare, Plasmatec, and Biotec)—as a consultant for the primer design and CE marking process.
• Quality/Regulatory Manager (April 2015–December 2016): Novacyt Group (Microgen Bioproducts, Lab21 Healthcare, Plasmatec, and Biotec).
• Overall Responsibility:

Successful completion of seven external audits (notified and certified bodies) with a maximum of 0 to 3 minor non-conformances per audit (2 sites: Microgen Bioproducts Ltd. and Lab21 Healthcare (Plasmatec and Biotec).

• Successful and effective transfer of site transition (Microgen)
• FDA audits Class II and Class I: Microgen Bioproducts
• Unannounced Audit from Notified Body List II A—Lab21 Healthcare
• Unannounced Audit from Notified Body List II B: Microgen Bioproducts Ltd.
• Recertification audit ISO 13485 and 9001—Lab21 Health Care
• Notified Body Audit: List IIA Products: Lab21 Healthcare
• Recertification audit ISO 13485 and 9001: Microgen Bioproducts
• Preparation for MDSAP
• Overall responsibility to maintain the quality management system, maintaining and enhancing existing company certifications where around 100 CE-marked and around 100 non-CE-marked products, 7 CMDCAS products, and around 20 FDA-Class II products.

• Was the first person for this company
• Implementation of QMS (ISO 13485)
• Managing and conducting internal and supplier (external) audits
• Hosting an external audit conducted by the certifying body (BSI) and successful achievement of ISO 13485
• Create and maintain technical files (CE marking) and design dossiers/DHF (FDA)
• Pre IDE initiation and discussion with FDA (Q Sub)
• Managing the site management review
• Create documents—manuals, forms, templates, procedures, etc.—as per CLSI, EP, Directive, FDA 21 CFR and ISO 13485.

• Design, develop, validate, and qualify multiplex of ELISA based Biochip array technology for various protein markers and PCR based multiplex DNA markers array
• This also includes preparation of SOP's, Work Instructions, DHF, Technical files and reports, QC test instruction, Formulation, dispense instruction, DMR, design transfer to production as per CE marking (IVD Directive 98/79/EC) FDA 510k
• Manage team for product formulation, optimisation, verification, stability, trials, manufacturing processes, QC for proteomic and genomic multiplex (PCR based) array in parallel time frame with deep prioritising knowledge as per GLP and GMP
• Apply state-of-the-art automated systems to above tasks when appropriate, including use in automated (Evidence), semi - auto automated (Evidence Investigator) and point of care systems
• Interpret and communicate experimental results through internal Biweekly, monthly and annual meetings
• Practise and improve the existing the quality management system (QMS) within the framework of ISO 13485 Quality Standards; In Vitro diagnostic medical device directive 98/79/EC, Canadian medical device regulation and Quality system regulation set out in part 820 of Title 21 code of Federal Regulations
• Trouble shoots and improve existing device as per technical support and customer support requirements
• Continuous improvement of device by CAPA
• Conducting Internal Audit process as per the Quality Assurance plan and participating FDA/CE marking audits
• Actively participate FDA auditing - Class II devices (IVD)
• From, CE marking and FDA clearance of the following IVD products