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Hire Dr. Sathesh Kumar A.

India

USD 50 /hr

Regulatory Affairs Specialist

Profile Summary

Fourteen years of R&D, Regulatory and Medical writing experience in various disciplines across In-vitro diagnostics, medical device regulations for CE Certification. • Experience in compilation, preparation, and review of the Performance evaluation plan and report, Analytical performance report, Clinical Performance report, and Scientific validity report. Preparation of GSPR, Gap assessment for IFUs (transition from IVDD to IVDR). • Experience in Authoring clinical trial protocols, clinical study reports, including Clinical Evaluation Plans and reports, Clinical Performance Reports, PMCF Plans and reports. • Good Knowledge on quality management (ISO xxxxxxxxxxxx) and regulatory requirements for medical devices and Invitro diagnostic devices –EU-MDR, EU-IVDR, USFDA 21CFR820. • Experience in analytical performance evaluation of IVD Medical devices in compliance with CLSI standards and regulatory requirements. Experience in handling clinical samples and ability to work in a BSL-2 environment. • Acts as Subject Matter Expert (SME) related to the biocompatibility evaluations of medical devices with Strong knowledge and hands-on experience in performance/evaluation of analyses including acute and chronic toxicity, cytotoxicity, sensitization, hemocompatibility, Genotoxicity, carcinogenicity according to ISO 10993 Standards, FDA Guidance. • Write and edit clinical development documents, including but not limited to clinical protocols, investigator s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials, and publications to medical journals.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ Point-of-Care Devices

Services

• Writing
• Research

Work Experience

Technical Manager (Senior Technical Lead)

HCL Technologies Ltd Chennai

February 2020 - Present

Head (R&D), Manager (Molecular Biology & Radioanalytical Facility)

Hubert Enviro Care Systems P Ltd

December 2018 - February 2020

Assistant Professor- Research

SRM University

July 2014 - December 2018

Senior Research Fellow

Bhabha Atomic Research Centre

July 2010 - December 2013

Junior Research Fellow

SRM University

July 2009 - June 2010

Education

Ph.D (Center For Environmental Nuclear Research)

SRM University

July 2009 - June 2014

M.Tech (Department of Biotechnology)

SRM University

July 2007 - July 2009

B.Tech (Industrial Biotechnology)

Anna University Chennai

July 2003 - June 2007

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

(2020). Multivariate analysis of heavy metal contamination in sediments of South East Coast of Tamilnadu, India.

(2020). Isolation and characterization of Metal Resistant Bacteria from incessant solid waste dumping yard. Journal of King Saud University – Science.

(2019). Comparative Antimicrobial and Anticancer Activity of Biologically and Chemically Synthesized Zinc Oxide Nanoparticles toward Breast Cancer Cells. BioNanoScience.

Raghavendra Ramalingam and Chetna Dhand and Chak Ming Leung and Seow Theng Ong and Sathesh Kumar Annamalai and Mohammed Kamruddin and Navin Kumar Verma and Seeram Ramakrishna and Rajamani Lakshminarayanan and Kantha Deivi Arunachalam(2019). Antimicrobial properties and biocompatibility of electrospun poly-ε-caprolactone fibrous mats containing Gymnema sylvestre leaf extract . Materials Science and Engineering: C. 98. p. 503 - 514.

Pamela Sinha, S. K. Annamalai, K. D. Arunachalam “A wee study of behavioural, organ somatic index and histological alterations of the freshwater fish Pangasius sutchi in response to protection studies, exposed to gamma radiation” ” Int. J. Pharm. Sci. Rev. Res., 49(3), April–May 2018; Pages 18-30 .

Jagannathan, P., Satyanarayanan, K., Annamalai, S.K., Arunachalam, K.D., Akansha(2018). Influence of bacteria bacillus sphaericus on water absorption and rapid chloride permeability properties in concrete . Journal of Advanced Research in Dynamical and Control Systems. 10. (8 Special Issue). p. 1113-1117.

Sinha, P., Arunachalam, K.D., Annamalai, S.K.(2018). Radio-protective dosimetry of Pangasius sutchi as a biomarker, against gamma radiation dosages perceived by genotoxic assays . Ecotoxicology and Environmental Safety. 164. p. 629-640.

Annamalai, S.K., Arunachalam, K.D.(2017). Uranium (²³⁸U)-induced ROS and cell cycle perturbations, antioxidant responses and erythrocyte nuclear abnormalities in the freshwater iridescent shark fish Pangasius sutchi . Aquatic Toxicology. 186. p. 145-158.

Annamalai, Sathesh Kumar and Arunachalam, Kantha Deivi(2017). Uranium (238U)-induced ROS and cell cycle perturbations, antioxidant responses and erythrocyte nuclear abnormalities in the freshwater iridescent shark fish Pangasius sutchi . Aquatic Toxicology. 186. (05). p. 145--158.

Annamalai, S.K., Arunachalam, K.D., Selvaraj, R.(2017). Natural radionuclide dose and lifetime cancer risk due to ingestion of fish and water from fresh water reservoirs near the proposed uranium mining site . Environmental Science and Pollution Research. p. 1-17.

Annamalai, S.K., Arunachalam, K.D.(2017). Uranium (²³⁸U) bioaccumulation and its persuaded alterations on hematological, serological and histological parameters in freshwater fish Pangasius sutchi . Environmental Toxicology and Pharmacology. 52. p. 262-275.

(2016). Analysis of Naturally Occurring 210Po in Sediments from Periyakalapattu to Parangipettai Coast of Tamilnadu, India . Journal of Radiation and Nuclear Applications.

Kannan, B., Sinha, P., Annamalai, S.K., Arunachalam, K.D.(2016). Bio decolorization of simulated dye waste water using Saccharomyces cerevisiae . Research Journal of Pharmaceutical, Biological and Chemical Sciences. 7. (5). p. 3022-3028.

Hari, Shanmugasundaram and Annamalai, Sathesh Kumar and Arunachalam, Kantha Deivi and Jha, V N and Sethy, N K and Sivasubramaniam, K and Krishnan, H and Devi, M Pandima(2016). Simulation Model for Feasibility Studies on Bioremediation of Uranium Mill Tailings using Hyper Accumulator Chrysopogon zizanioides . American Journal of Environmental Sciences. 12. (6). p. 370--378.

Harikrishnan, N and Ravisankar, R and Gandhi, M Suresh and Arunachalam, Kantha Deivi and Annamalai, Sathesh Kumar(2016). Analysis of Naturally Occurring 210 Po in Sediments from Periyakalapattu to Parangipettai Coast of Tamilnadu , India. Journal of Radiation and Nuclear Applications. 16. (1). p. 11--16.

Shanmugasundaram, H., Annamalai, S.K., Arunachalam, K.D., Jha, V.N., Sethy, N.K., Sivasubramaniam, K., Krishnan, H., Pandima Devi, M.(2016). Simulation model for feasibility studies on bioremediation of uranium mill tailings using hyper accumulator Chrysopogon zizanioides . American Journal of Environmental Sciences. 12. (6). p. 370-378.

Arunachalam, K.D., Kuruva, J.K., Hari, S., Annamalai, S.K., Baskaran, K.V.(2015). HPTLC finger print analysis and phytochemical investigation of morinda tinctoria roxb leaf extracts by hplc and gs ms . International Journal of Pharmacy and Pharmaceutical Sciences. 7. (2). p. 360-366.

Arun, L.B., Arunachalam, A.M., Arunachalam, K.D., Annamalai, S.K., Kumar, K.A.(2014). In vivo anti-ulcer, anti-stress, anti-allergic, and functional properties of Gymnemic Acid Isolated from Gymnema sylvestre R Br . BMC Complementary and Alternative Medicine. 14.

Arunachalam, Kantha Deivi and Baskaran, Kamesh Viswanathan and Annamalai, Sathesh Kumar and Sivasubramani, S. and Venkatraman, B.(2014). Ingestion of 210Po by public residing in and around Kalpakkam through dietary source . International Nuclear Information System. 46. (36). p. 187.

Arunachalam, K D and Baskaran, Kamesh Viswanathan and Rao, D D and Sathyapriya, R and Annamalai, Sathesh Kumar and Kuruva, Jaya Krishna and Hari, Shanmugamsundaram(2014). Ingestion of Polonium ((210)Po) via dietary sources in high background radiation areas of south India . International journal of radiation biology. 90. (10). p. 867--875. Informa Healthcare

Arunachalam, K., Annamalai, S.K., Arunachalam, A.M., Raghavendra, R., Kennedy, S.(2014). One step green synthesis of phytochemicals mediated gold nanoparticles from Aegle marmales for the prevention of urinary catheter infection . International Journal of Pharmacy and Pharmaceutical Sciences. 6. (1). p. 700-706.

Arunachalam, K.D., Baskaran, K.V., Rao, D.D., Sathyapriya, R., Annamalai, S.K., Kuruva, J.K., Hari, S.(2014). Ingestion of Polonium (²¹⁰Po) via dietary sources in high background radiation areas of south India . International Journal of Radiation Biology. 90. (10). p. 867-875.

Arunachalam, Kantha Deivi and Arun, Lilly Baptista and Annamalai, Sathesh Kumar and Arunachalam, Aarrthy M.(2014). Potential anticancer properties of bioactive compounds of Gymnema sylvestre and its biofunctionalized silver nanoparticles . International Journal of Nanomedicine. 10. p. 31--41.

Arunachalam, K D and Annamalai, S K and Baskaran, K V and Rajaram, S and Jha, S K and Sreedevi(2014). Spatial and multivariate analysis of trace elements in the surface water and deep sediments of fresh water aquatic ecosystem . American Journal of Environmental Sciences. 10. (2). p. 102--122.

Arunachalam, K.D., Annamalai, S.K., Baskaran, K.V., Rajaram, S., Jha, S.K., Sreedevi(2014). Spatial and multivariate analysis of trace elements in the surface water and deep sediments of fresh water aquatic ecosystem . American Journal of Environmental Sciences. 10. (2). p. 102-122.

Arunachalam, K.D., Arun, L.B., Annamalai, S.K., Arunachalam, A.M.(2014). Potential anticancer properties of bioactive compounds of Gymnema sylvestre and its biofunctionalized silver nanoparticles . International Journal of Nanomedicine. 10. p. 31-41.

Annamalai, Sathesh Kumar and Arunachalam, Kantha Deivi(2014). Uranium induced ROS and its antioxidant defense molecules, genotoxicity assessment in iridescent shark (Pangasius sutchi) . International Nuclear Information System. 46. (36). p. 314.

Raghavendra, R., Arunachalam, K., Annamalai, S.K., Arunachalam, A.M.(2014). Diagnostics and therapeutic application of Gold nanoparticles . International Journal of Pharmacy and Pharmaceutical Sciences. 6. (SUPPL. 2). p. 74-87.

Baskaran, Kamesh Viswanathan and Arunachalam, Kantha Deivi and Annamalai, Sathesh Kumar and Kuruva, Jaya Krishana and Rao, D. D.(2014). Comparison of alkali fusion and acid digestion methods for radiochemical separation of Uranium from dietary samples . International Nuclear Information System. 46. (23). p. 334.

Arunachalam, K.D., Arun, L.B., Annamalai, S.K., Arunachalam, A.M.(2014). Biofunctionalized gold nanoparticles synthesis from Gymnema sylvestre and its preliminary anticancer activity . International Journal of Pharmacy and Pharmaceutical Sciences. 6. (4). p. 423-430.

Arunachalam, Kantha Deivi and Hari, Shanmugasundaran and Annamalai, Sathesh Kumar and Baskaran, Kamesh and Viswanathan and Jha, V. N. and Sethy, N. K. and Sivasubramanian, K.(2014). Evaluation of the uranium immobilization potential of vetiver plants grown on processed solid waste of uranium industry of Jaduguda, India . International Nuclear Information System. 46. (36). p. 113.

Arun, Lilly Baptista and Arunachalam, Aarrthy M and Arunachalam, Kantha Deivi and Annamalai, Sathesh Kumar(2014). In vivo anti-ulcer, anti-stress, anti-allergic, and functional properties of Gymnemic Acid Isolated from Gymnema sylvestre R Br . BMC complementary and alternative medicine. 70. (14). p. 1--11.

Arunachalam, Kantha Deivi and Arun, Lilly Baptista and Annamalai, Sathesh Kumar and Hari, Shanmugasundaran(2014). Gymnemagenin-a triterpene saponin prevents $γ$-radiation induced cellular DNA damage . International Nuclear Information System. 46. (36). p. 73.

Arunachalam, K.D., Annamalai, S.K., Kuruva, J.K.(2014). In-vivo evaluation of hexavalent Chromium induced dna damage by alkaline comet assay and oxidative stress in Catla catla . American Journal of Environmental Sciences. 9. (6). p. 470-482.

Arunachalam, K D and Annamalai, S K and Kuruva, J K(2013). In-vivo evaluation of hexavalent Chromium induced dna damage by alkaline comet assay and oxidative stress in Catla catla . American Journal of Environmental Sciences. 9. (6). p. 470--482. Science Publications

Jin, G and Prabhakaran, M P and Kai, D and Annamalai, S K and Arunachalam, K D and Ramakrishna, S(2013). Tissue engineered plant extracts as nanofibrous wound dressing . Biomaterials. 34. (3). p. 724--734.

Jin, G., Prabhakaran, M.P., Kai, D., Annamalai, S.K., Arunachalam, K.D., Ramakrishna, S.(2013). Tissue engineered plant extracts as nanofibrous wound dressing . Biomaterials. 34. (3). p. 724-734.

Annamalai, S.K., Arunachalam, K.D., Sathyanarayanan, K.S., Kumar, V.R.P.(2013). Characterization and applications of biocement enchanced with carbon nanotubes for improved remediation on cracked concrete structures . Asian Journal of Chemistry. 25. (SUPPL).

Arunachalam, K.D., Annamalai, S.K.(2013). Chrysopogon zizanioides aqueous extract mediated synthesis, characterization of crystalline silver and gold nanoparticles for biomedical applications . International Journal of Nanomedicine. 8. p. 2375-2384.

Arunachalam, K.D., Annamalai, S.K., Arunachalam, A.M., Kennedy, S.(2013). Green synthesis of crystalline silver nanoparticles using Indigofera aspalathoides-medicinal plant extract for wound healing applications . Asian Journal of Chemistry. 25. (SUPPL).

Arunachalam, K D and Annamalai, S K and Hari, S(2013). One-step green synthesis and characterization of leaf extract-mediated biocompatible silver and gold nanoparticles from Memecylon umbellatum . International Journal of Nanomedicine. 8. p. 1307--1315.

Arunachalam, K.D., Annamalai, S.K., Hari, S.(2013). One-step green synthesis and characterization of leaf extract-mediated biocompatible silver and gold nanoparticles from Memecylon umbellatum . International Journal of Nanomedicine. 8. p. 1307-1315.

Annamalai, Sathesh Kumar and Arunachalam, Kantha Deivi and Kuruva, Jaya Krishna and Jha, S.K. and Rajaram, S.(2013). Polonium (210Po) distribution pattern in the fresh water ecosystem of Nagarjuna Sagar Dam, Andhra Pradesh, India . International Nuclear Information System. 46. (37). p. 179--183.

Meenakumari, S., Arunachalam, K.D., Kumar, A.S.(2013). Screening and characterisation of silver nanoparticles for the prevention of biofilm in urinary catheters . Asian Journal of Chemistry. 25. (SUPPL).

Arunachalam, Kantha D., Subhashini, S., Annamalai, Sathesh Kumar(2012). Wound healing and Antigenotoxic activities of Aegle marmelos with relation to its antioxidant properties. Journal of Pharmacy Research. 5. (3). p. 1492-1502.

Arunachalam, Kantha D and Arunachalam, Aarrthy M and Jayakrishna, K and Annamalai, Sathesh Kumar(2012). Radioprotective Properties Of Casein Phospho Peptides (CPP) In Gamma Irradiated Animal Models . International Nuclear Information System. 44. (30). p. 290--292.

Viswanathan, B Kamesh and Arunachalam, Kantha D and Rao, D D and Annamalai, Sathesh Kumar and Jayakrishna, K(2012). Concentration Of 210 Po In Local Foodstuffs grown Nearby High Background Areas ( HBRA ) . International Nuclear Information System. 44. (30). p. 562--563.

Annamalai, S.K., Arunachalam, K.D., Sathyanarayanan, K.S.(2012). Production and characterization of Bio Caulk by Bacillus pasteurii and its remediation properties with carbon nano tubes on concrete fractures and fissures . Materials Research Bulletin. 47. (11). p. 3362-3368.

Subashini, S., D.Arunachalam, Kantha, Annamalai, Sathesh Kumar(2011). Preclinical studies on the Phytochemical , Antimicrobial , and Wound healing properties of Indigofera aspalathoides leaves. Journal of Pharmacy Research. 4. (9). p. 3206-3211.

Sathesh Kumar Annamalai, Kantha D. Arunachalam, K.S. Sathyanarayanan, 2012, 'Production and characterization of Bio Caulk by Bacillus pasteurii and its remediation properties with carbon nano tubes on concrete fractures and fissures', <i>Materials Research Bulletin</i>, vol. 47, no. 11 .

CONFERENCE PAPER

Jagannathan, P., Satya Narayanan, K.S., Arunachalam, K.D., Annamalai, S.K.(2018). Studies on the mechanical properties of bacterial concrete with two bacterial species . Materials Today: Proceedings. 5. (2). p. 8875-8879.

OTHER

Tissue engineered plant extracts as nanofibrous wound dressing .