Yogesh Kumar, Phd
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Yogesh Kumar, Phd Email & Phone Number

Product Compliance Manager at Lindy Electronics Limited at Lindy Electronics Limited
Location: Durham, England, United Kingdom 10 work roles 2 schools
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Product Compliance Manager at Lindy Electronics Limited
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Durham, England, United Kingdom
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Yogesh Kumar, Phd is listed as Product Compliance Manager at Lindy Electronics Limited at Lindy Electronics Limited, a with 38 employees, based in Durham, England, United Kingdom. AeroLeads shows a matched LinkedIn profile for Yogesh Kumar, Phd.

Yogesh Kumar, Phd previously worked as Product Compliance Manager at Lindy Electronics Limited and Lead Internal Auditor at Helena Biosciences. Yogesh Kumar, Phd holds Doctor Of Philosophy - Phd, Organic Chemistry from Punjab Technical University.

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Lindy Electronics Limited

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About Yogesh Kumar, Phd

With a doctorate in Chemistry and Chartered status, I have cultivated a diverse and extensive career spanning the pharmaceutical, medical device, and electronics (EEE) sectors. My professional journey has equipped me with a robust skill set in development, quality control, compliance, safety, and regulatory affairs, enabling me to contribute effectively. This comprehensive experience forms the backbone of my career and has been instrumental in driving success across various projects and roles.Professional Experience and ExpertiseElectronics (EEE) & Medical Device Sector: My work has been focused on managing regulatory compliance and product safety for electronic and electrical & medical equipment. Key areas of expertise include: - RoHS Directive Compliance - REACH Regulation - US Toxic Substances Control Act (TSCA) - California Proposition 65 (CP65) - Ecodesign for Sustainable Products Regulation (ESPR) - WEEE Directive - Electromagnetic Compatibility (EMC) - Radio Equipment Directive (RED) - Low Voltage Directive (LVD) - CB Scheme - EU Battery Regulation - EU Packaging Regulations (PPWR) - Conflict Minerals Reporting - ISO 13485:2016 - 21 CFR Part 820 - Extended Producer Responsibility (EPR) - ISO Management Systems - Audit Planning and Execution - Non-Conformity Management - Continuous ImprovementSustainability and Compliance Integration: A significant part of my career has been dedicated to integrating compliance and sustainability goals, ensuring that products not only meet regulatory requirements but also contribute to broader environmental and social objectives. Key initiatives include: - Product Sustainability - Environmental, Social, and Corporate Governance (ESG) - Corporate Social Responsibility (CSR)Strategic Leadership and Policy Development: Throughout my career, I have successfully developed and implemented strategies, policies, and procedures to ensure compliance with a wide array of product-related legislation globally. Key achievements include: - Global Regulatory Strategy - Policy Development - Regulatory Documentation such as CE/UKCA, dossiers etc

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Lindy Electronics Limited
Lindy Electronics Limited
Product Compliance Manager at Lindy Electronics Limited
united kingdom
Website
Employees
38
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10 roles

Yogesh Kumar, Phd work experience

A career timeline built from the work history available for this profile.

Product Compliance Manager

Current

Stockton-On-Tees, England, United Kingdom

▪ Maintain broad compliance for global, regional, local product regulations and standards of handling hazardous chemicals and interpret their implications for the organization.▪ Conduct comprehensive risk assessments to identify potential compliance gaps and develop strategies to mitigate risks.▪ Collaborate with cross-functional teams to integrate compliance requirements to the different business divisions around the world.▪ Develop and implement strategies, policies, and procedures to ensure compliance with product-related legislation such as REACh, RoHS, POP, CP65, TSCA, PFAS, MCCP, FCC, RED, EMC, CB and LVD etc, packaging and batteries in markets worldwide and prepare Declaration of Conformity (CE, UKCA). ▪ Support business departments through the compliance program and maintaining compliance database and REACh Docstore; Monitoring REACh, SCIP registration dossiers, Conflict Mineral CMRT and consistency of information communicated within supply chain.▪ Working closely with the global product management team on all aspects of EPR, product management, new product introduction (NPI) and product life cycle management. ▪ Collaborate with compliance bodies, export control organizations, test houses, customers, suppliers, and audit bodies to address regulatory issues and maintain compliance.▪ Engage with regulatory authorities, industry groups, and certification bodies to stay informed about emerging regulations and industry best practices.▪ Provide regulatory advice and support to commercial teams, ensuring all products listed globally meet necessary regulatory certifications and compliance standards. ▪ Investigate compliance incidents, implement corrective actions, and develop preventive measures to avoid future non-compliance.▪ Support Business level responses to key customer requests on Product Compliance. Provide product management support and advice for the sales, SCM, marketing, SCM, QC and warehouse departments whenever required.

May 2023 - Present

Lead Internal Auditor

Gateshead, England, United Kingdom

• Perform the review/approval of GxP documents, including protocols, technical specification (TS) and SOPs for characterization and quality control of biopharmaceutical products for medical devices in Chemistry, Pathology, Oncology etc.• Conduct in -process and product quality audits across Operations areas to ensure compliance to Quality Management System, GMP or GLP, CLSI, Regulatory Standards. • Ensures that the unit is aligned with the MHRA, BSI, IVDR, EU GMP, 21 CFR 820/803 requirements.• Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for Audits. Constantly work within Operational departments to reduce the risk of quality findings.• Accountable for management of product release processes, ensuring product meets specification & customer order/prescription and is released according to schedule.• Write reports, review method, SOPs, validation/transfer protocols/reports, and other relevant sections of regulatory filings/registration, consent documents for ethics, FDA, IVDR submissions, GCP & GMP regulatory, FMEA and quality standards.• Staff development, training and mentoring, leading the objective setting, performance management, training & development as well as assist in recruitment of the project.

Apr 2021 - Mar 2023

Applications Scientist

Gateshead, England, United Kingdom

• Design, develop, validate and transfer biochemical methods such as capillary electrophoresis (CE) methods for characterization and quality control of biopharmaceutical products for medical devices in areas of Clinical Chemistry, Pathology, Oncology etc.• Develep new chemistry and implement innovative separation technology to meet increasing analytical challenges for new modalities.• Optimize and troubleshooting of analytical methods, participate in qualification, transfer and validation experiments with a focus on separation-based purity methods.• Optimization of new products from R&D laboratory to production environment ensuring full execution of data quality, accuracy, development of policies, standards, procedures to final reconciliation to review and evaluate for successful completion. • Lead continuous improvement to improve & maintain quality. Investigate causes of quality failures and introduce sustainable corrective actions. • Conduct in -process and product quality audits across Operations areas to ensure compliance to Quality Management System, GMP or GLP, CLSI, Regulatory Standards. • Ensures that the unit is aligned with the MHRA, BSI, IVDR and EU GMP requirements.• Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for Audits. Assist ISO 9001 and ISO 13485 within the business. • Manage complaints & nonconformances from root cause analysis. Keep calibration/maintenance records and procedures up to date.• Write reports, review method, SOPs, validation/transfer protocols, and other relevant sections of regulatory filings/registration, consent documents for ethics and FMEA.

Apr 2021 - Feb 2023

Northern Power Inclusion Matters

United Kingdom

Leadership, cross-institutional networking, mentoring and multidisciplinary development program to support Early Career Researchers (ECR).

Jan 2020 - Jan 2021

Postdoctoral Research Associate

Durham, United Kingdom

- Designing, synthesis, purification and characterisation of new fluorescent organic probes.- Validate fluorescent molecular probes for quantifying the chemical reactivity of drug molecules in lipid membranes- Deal with problems that may affect the achievement of research objectives and deadlines, especially related to (a) the design and synthesis of new labelled molecules; (b) the development of plate-based screens for drug screening; (c) method validation.- Conduct individual and collaborative research projects.- Assist with the development of research objectives and proposals.- Manage, plan and prioritise research within the agreed framework of the project, including planning.- Write, or assist writing, the results of the research in a form suitable for presentation at meetings, patents and manuscripts for submission.- Contribute to the general day-to-day running of the laboratory to a high standard.

Apr 2019 - Sep 2020

Equality, Diversity And Inclusion (Edi ) Committee Member

Durham, England, United Kingdom

The Committee ensure that there is an integrated, proactive approach to equality, diversity and inclusion that meets the University’s public sector equality duties, informed by sector best practice and supports the achievement of the University’s values and objectives. The Committee recognises both the impact of individual characteristics as well as the role of intersectionality in Equality, Diversity and Inclusion.Responsibilities:Without limiting the general responsibilities as described above:- To develop and review the University’s Equality, Diversity and Inclusion strategy and to drive and oversee the University’s commitment to and progress on its delivery.- To monitor and report on the University’s compliance with equality, diversity and inclusion legislation.- To plan, review and approve the University’s information reporting of relevance to Equality, Diversity and Inclusion.- To make recommendations and support University staff and students in implementation of institutional level equality objectives and to monitor progress regularly towards achieving these objectives.- To guide the University’s approach to relevant charter mark activities and make recommendations for sharing best practice across the University.- To champion diverse representation on all institutional committees.- To establish and monitor such sub-groups as may be required to deliver specific areas of the Committee’s remit.- To receive reports and updates from its sub-groups and where relevant from other University Executive Board committees, and coordinate with parallel activities as required at University.- The Chair of the Committee is accountable for the decisions of the Committee which includes but is not limited to decisions with a financial impact and will liaise with the chairs of other committees and other budget holders where there is overlap in responsibility.

Oct 2019 - Aug 2020

First Aider

Durham, England, United Kingdom

To provide immediate, lifesaving, medical care before the arrival of further medical help. This includes performing procedures such as: Placing an unconscious casualty into the recovery position, Performing Cardiopulmonary resuscitation (CPR), Using an automated external defibrillator (AED), Protect the casualty from any danger, Arrange for the right kind of help.

Oct 2019 - Jul 2020

Postdoctoral Research Associate

Ankara, Turkey

- My research project combines synthetic organic, supramolecular and polymer chemistry to prepare functional materials.- Designing and synthesis of fluorescent multi-glycosylated conjugated supramolecular assemblies based on porphyrins, cucurbiturils and fluorenes with potential applications in the areas of photonics, photocatalysis, bionanotechnology. - Utilization of synthesized fluorescent conjugated supramolecular assemblies in drug delivery and as a photocatalysts for water splitting.- Standard analytical methods: separation, characterization and purification viz. TLC, prep-TLC, column chromatography, NMR (1H, 13C), 2D NMR, UV-Visible-, IR-, Fluorescence-, Mass spectroscopy, DLS (dynamic light scattering) and ZP (zeta potential), Scanning electron microscope (SEM), Brunauer, Emmett and Teller (BET), lyophilizer etc.

Feb 2018 - Mar 2019

Research Associate

Manesar, Haryana

Highlights: ➢ Multi-step organic synthesis of medicinal compounds, identification, optimization and development of lead molecules and new targets for drug discovery➢ Optimization and scale up from milligram to multi-gram level for industrial set-up using environmental friendly and economical synthesis.➢ Developing a chemical transformation based drug modification technologies, which aids drug development of lead molecules or approved APIs.➢ Heterocyclic ring systems such as Imidazo-pyrazines, Imidazo-triazines, Aza-indoles, Pyrazoles, Pyrrolo-pyridines, Pyrimidines, Purines, Indoles, Pyridines, benzimizazoles, benzothiazoles, etc.➢ Cross coupling reactions using transition metal catalysts such as Suzuki, Suzuki-Miyaura, Stille, Sonogashira, Buckwald- Hartwing, Heck reactions etc.➢ Purification and characterization of organic compounds using various analytical techniques viz. NMR (1H, 13C), 2D NMR (COSY, NOESY, HMBC & HMQC etc.), HPLC, prep-HPLC & Mass spectroscopy (LCMS/MALDI).➢ Draft, review and analyze scientific reports and other regulatory documents.

Jun 2016 - Nov 2017

Assistant Professor

Jalandhar

- Teaching and supervising undergraduate and graduate students.- Providing demonstrations and supervising experiments and investigations.- Assisting with various departmental duties and providing academic support to colleagues and other staff.- Training, and mentoring new TAs and other junior staff.- Conducting research and publishing papers in academic journals.- Representing the university at conferences and delivering presentations when necessary.

Aug 2010 - May 2011
Team & coworkers

Colleagues at Lindy Electronics Limited

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2 education records

Yogesh Kumar, Phd education

Doctor Of Philosophy - Phd, Organic Chemistry

Achievements: ➢ Diastereoselective synthesis of novel diaza-bicyclo[3.2.0]heptan-7-one by intramolecular endo-trig haloamination.

FAQ

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What company does Yogesh Kumar, Phd work for?

Yogesh Kumar, Phd works for Lindy Electronics Limited.

What is Yogesh Kumar, Phd's role at Lindy Electronics Limited?

Yogesh Kumar, Phd is listed as Product Compliance Manager at Lindy Electronics Limited at Lindy Electronics Limited.

Where is Yogesh Kumar, Phd based?

Yogesh Kumar, Phd is based in Durham, England, United Kingdom while working with Lindy Electronics Limited.

What companies has Yogesh Kumar, Phd worked for?

Yogesh Kumar, Phd has worked for Lindy Electronics Limited, Helena Biosciences, Epsrc, Durham University, and Bilkent University.

Who are Yogesh Kumar, Phd's colleagues at Lindy Electronics Limited?

Yogesh Kumar, Phd's colleagues at Lindy Electronics Limited include Allen Liu, Zaid Mahmood, Gerald Casey, Giuseppe Calcaterra, and Owen Haigh.

How can I contact Yogesh Kumar, Phd?

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What schools did Yogesh Kumar, Phd attend?

Yogesh Kumar, Phd holds Doctor Of Philosophy - Phd, Organic Chemistry from Punjab Technical University.

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