プロフィール詳細

プロジェクトを作成

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Dr. Samundeeswari M.に依頼

India

PhD Scientist | Regulatory Affairs Associate (Medical Devices) | Technical Writing & Global Compliance

プロフィール概要

I’m a PhD chemist with 9+ years of research experience in fluorine chemistry and radioactive materials, now transitioning into regulatory affairs for medical devices. With 28 peer-reviewed publications, multiple international presentations, and leadership in cross-functional projects, I bring a strong foundation in scientific analysis, documentation, and problem-solving to regulatory work. Currently an active member of RAPS and a 2025 RAC (Regulatory Affairs Certification) candidate, I specialize in interpreting and applying FDA and international medical device regulations. I offer support in: Regulatory document preparation (e.g., 510(k), CE technical files, clinical evaluation reports) Scientific literature reviews for compliance and submissions Gap analysis against FDA, EU MDR, and IMDRF guidelines Technical writing and quality system documentation (SOPs, risk management, labeling) I bridge the gap between science and compliance—ensuring medical technologies meet global standards while accelerating time to market. Whether you need support on a submission, a regulatory strategy review, or scientific writing for a compliant dossier, I can help. Let’s connect to explore how I can support your regulatory needs with precision and purpose.

専門分野

• ☆ Coordination Compounds
• ☆ Spectroscopy
• ☆ Radiochemistry
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ Nonclinical Study Documentation

サービス

• Writing
• Research

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing

Research Gap Analysis, Systematic Literature Review

職務経験

Assistant Researcher Professor

University of Nevada Las Vegas

2017 - 2021

Post-doctorate

University of Nevada Las Vegas

3月 2015 - 8月 2017

学歴

Doctorate

Freie Universität Berlin

1月 2021 - 1月 2021

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

James Louis-Jean and Samundeeswari M. Balasekaran and Keith V. Lawler and Adri{\'{a}}n Sanchis-Perucho and Jos{\'{e}} Mart{\'{\i}}nez-Lillo and Dean Smith and Paul M. Forster and Ashkan Salamat and Frederic Poineau(2021). Coexistence of metamagnetism and slow relaxation of magnetization in ammonium hexafluoridorhenate . RSC Advances. 11. (11). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 6353--6360. Royal Society of Chemistry ({RSC})

Samundeeswari Mariappan Balasekaran and Adelheid Hagenbach and Frederic Poineau(2020). Towards mid-valent rhenium fluoro-phosphine complexes via hexafluoridorhenate(IV) anion pathway assisted by trifluoro acetic acid . Inorganic Chemistry Communications. 119. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 108064. Elsevier {BV}

Samundeeswari Mariappan Balasekaran and Frederic Poineau(2019). Bis(tetraphenylarsonium) hexafluoridotechnetate(IV) dihydrate: preparation, structure and spectroscopic analysis . Acta Crystallographica Section C Structural Chemistry. 75. (12). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1613--1616. International Union of Crystallography ({IUCr})

Frederic Poineau and James Louis-Jean and Harry Jang and Cassara Higgins and Samundeeswari Mariappan Balasekaran and David Hatchett and Alfred P. Sattelberger(2019). X-ray absorption fine structure spectroscopic study of (NH4)2ReF6 . SN Applied Sciences. 1. (11). Springer Science and Business Media {LLC}

Samundeeswari Mariappan Balasekaran and Keith Lawler and Adelheid Hagenbach and Andrea Abram and Ulrich Abram and Alfred Sattelberger and Frederic Poineau(2019). Uncovering Multiple Metal–Metal Bonding in a Tetranuclear Fluoride Rhenium Cluster or the Curious Case of {[Ni(H 2 O) 6 ](NH 4 ) 4 }[Re 4 F 18 ]·4H 2 O . European Journal of Inorganic Chemistry. 2019. (38). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 4129--4135. Wiley

Samundeeswari Mariappan Balasekaran and Adelheid Hagenbach and Dieter Lentz and Frederic Poineau(2019). Tetraethylammonium Hexafluoro Uranate(IV), Hafnate(IV), and Cerate(IV) Salts: Preparation and Solid‐state Structure . Zeitschrift für anorganische und allgemeine Chemie. 645. (16). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1052--1056. Wiley

James Louis{\textendash}Jean and Samundeeswari Mariappan Balasekaran and Adelheid Hagenbach and Frederic Poineau(2019). An unexpected rhenium(IV)–rhenium(VII) salt: [Co(NH3)6]3[ReVIIO4][ReIVF6]4·6H2O . Acta Crystallographica Section E Crystallographic Communications. 75. (8). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1158--1161. International Union of Crystallography ({IUCr})

N. Johns and S. Mariappan Balasekaran and A. Chang and P.K. Bhowmik and F. Poineau(2019). Preparation and molecular structure of lanthanum–FcCOO−–DTBbpy complexes . Inorganica Chimica Acta. 489. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 115--119. Elsevier {BV}

Samundeeswari Mariappan Balasekaran and Alfred Peter Sattelberger and Bruce Noll and Adelheid Hagenbach and Frederic Poineau(2019). Difluorotetrakis(2-oxypyridine)dirhenium(III) - Preparation, Crystallographic Structure, and Electrochemical Properties . Zeitschrift für anorganische und allgemeine Chemie. 645. (1). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 27--30. Wiley

P. J. Skrodzki and M. Burger and L. A. Finney and F. Poineau and S. M. Balasekaran and J. Nees and K. R. Czerwinski and I. Jovanovic(2019). Standoff detection of uranyl fluoride using ultrafast laser filamentation-induced fluorescence . Conference on Lasers and Electro-Optics. {OSA}

P. J. Skrodzki and M. Burger and L. A. Finney and F. Poineau and S. M. Balasekaran and J. Nees and K. R. Czerwinski and I. Jovanovic(2018). Ultrafast Laser Filament-induced Fluorescence Spectroscopy of Uranyl Fluoride . Scientific Reports. 8. (1). Springer Science and Business Media {LLC}

S. Mariappan Balasekaran and Adelheid Hagenbach and Ulrich Abram(2018). Tetrafluoridonitridotechnetate(VI) - Reactions and Structures . Zeitschrift für anorganische und allgemeine Chemie. 644. (19). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1158--1163. Wiley

S. Mariappan Balasekaran and J. J. Koh and H. Han and P. K. Bhowmik and B. C. Noll and F. Poineau(2018). Synthesis and Structure of Di(1,2,4,6-tetraphenylpyridinium) Octachlorodirhenate(III) . Crystallography Reports. 63. (4). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 570--573. Pleiades Publishing Ltd

S. M. Balasekaran and A. Hagenbach and M. Drees and U. Abram(2017). [TcII(NO)(trifluoroacetate)4F]2−– synthesis and reactions . Dalton Trans. 46. (39). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 13544--13552. Royal Society of Chemistry ({RSC})