Summary
Overview
Work History
Education
Skills
Certification
Publications
Awards
Personal Information
Timeline
Generic

Kalyan Kumar Gopal

Montgomery Village,USA

Summary

With a proven track record at Beckton Dickinson, I excel in strategic leadership and project management, adeptly navigating regulatory landscapes. My expertise in regulatory strategy and analytical thinking has driven successful compliance and product development projects, showcasing a commitment to operational excellence and innovative solutions. Versatile manager with background in coordinating diverse teams and managing complex projects. Skilled in strategic planning, operational improvement, and fostering collaborative environments. Demonstrated ability to enhance efficiency and productivity while maintaining high standards of quality. Successfully implemented innovative solutions that resulted in positive organizational changes.

Overview

23
23
years of professional experience
1
1
Certification

Work History

Associate Director – Regulatory affairs

QIAGEN Inc
Germantown, USA
04.2021 - Current
  • Responsible for developing strategy for product development and registrations
  • Conducted comprehensive evaluations of compliance across the QIAGEN portfolio in collaboration with the Franchise Team
  • Supported compliance issues and managed deficiency letters related to the design, development, and manufacture of device portfolio
  • Communicated directly with Notified Bodies (BSI/TUV) on observations, ensuring timely investigation, corrective actions, and compliance with all regulatory timelines
  • Maintained up-to-date knowledge of regulatory requirements and interpretations, providing insights on Quality & Regulatory compliance across US, EU, and ROW markets
  • Led timely communication and escalation of quality systems and compliance risks
  • Created and updated QARA-related SOPs for smooth submissions, including 510(k) and EU Technical Files
  • Provided strategic support and collaborated with cross-functional teams to develop strategies and tools for external audit readiness (QMS & MDSAP audits)
  • Streamlined Notified Body queries with lessons learned to enhance efficiency and compliance
  • Initiated regulatory intelligence for an easy life cycle management approach
  • Drove improvements in internal and external audit metrics to ensure ongoing compliance and operational excellence
  • Assisted senior leadership in managing all aspects of operations
  • Managed cross-functional teams for multiple large-scale projects, successfully completing each on time and within budget constraints
  • Reviewed proposed regulatory changes and evaluated potential impacts on business operations
  • Supported capital project planning and contributed to feasibility studies
  • Provided strategic analysis for manufacturing life cycles, technologies, process validations, and robustness

Senior Manager

Beckton Dickinson
08.2016 - 04.2022
  • Company Overview: Deployed in Beckton, Dickinson, Sparks for the MDR and IVDR implementation project by HCL.
  • Identifies issues to be addressed and areas of concern where MDR and IVDR may hinder the registration.
  • Prepares and communicates MDR-IVDR project-related documentation (2017–2022).
  • Successfully led a team of cross-functional subject matter authorities in a highly matrixed organization.
  • Leads teams that are necessary to complete required changes, including systems support and development, labeling, processes for products in the EU, and supports efforts to manage Economic Operators and other duties.
  • Participates and coordinates with the CFT to ensure compliance with the quality system.
  • Ability to lead multiple projects concurrently.
  • Monitors and interprets IVDR regulations and guidelines, and interacts with project teams to provide guidance to complete deliverables per established deadlines.
  • Works closely with the Program Director on all matters to assure consistency and alignment between third parties and the Regulatory departments of BD.
  • Reviews and/or audits data related to regulatory projects and functions.
  • Carries out duties in compliance with established business policies.
  • Collaborates well with others, building effective working relationships; negotiates to build broad-based support, and/or persuades others to influence meaningful outcomes.
  • Deployed in Beckton Dickinson Sparks for the MDR and IVDR implementation project by HCL.

Associate Scientist III – Biocompatibility and Toxicology Studies.

Kemin Industries (Vanta Bioscience)
07.2010 - 08.2016
  • Company Overview: CRO (Pharma & Device)
  • Coordinate in performing sterilization and bio-compatibility studies (ISO:10993)
  • Perform polymer material selection for the medical device based on the clinical compatibility and by understanding the manufacturing method of the materials
  • Design, plan and conduct clinical research trials by effectively coordinating the activities of study coordinators and investigators and by ensuring compliance with study protocols, GLP, GCP, FDA and International regulations, IRB and/or Ethics committees' requirements and overall clinical objectives
  • Co-ordinate in performing pre-clinical studies, animal study with approval from CPCSEA and IAEC
  • Obtain approval from regulatory boards for conducting clinical trial
  • Attend relevant scientific and/or medical meetings
  • Includes 30 to 50% travel
  • Develop and implement strategies for the earliest possible approval of regulatory submission
  • CRO (Pharma & Device)

Research Associate (Preclinical / Safety Pharmacology)

Orchid Research Laboratory Limited
01.2005 - 07.2010
  • Company Overview: Drug Discovery
  • Responsible for Pharmacological, molecular and cellular models for NCES
  • Actively involved in establishing NCE for Oncology and Inflammation (OCID 2287/5005)
  • Worked and Achieved GLP/AAALAC Certification as a Team member
  • Design, conduct and monitoring of Preclinical studies for Pharmaceuticals, IVD, Medical devices and Cosmetics
  • Preparation and peer review reports for GLP compliance as per OECD, EPA, and ICH guidelines
  • Implementation of new testing models for toxicology studies
  • Regular communication with clients, hosting client visits and inspections
  • Facilitate collaboration with academic centers as necessary to complete investigative studies
  • Drug Discovery

Microbiologist

Minister of Health Malaysia
, Malaysia
04.2002 - 09.2005
  • Involving disease diagnosis testing methods in hematology, clinical chemistry, and endocrinology
  • Analysis of hematological parameters such as complete blood picture, blood gas and electrolyte analysis
  • Tools and Technology used: CLSI standards / Microbiology Guidelines

Education

PhD - Microbiology

University of Madras
Chennai, Tamil Nadu
01.2011

MPhil - Biotechnology

Periyar University
Salem, Tamil Nadu
07.2007

M.Sc - Microbiology

Madurai Kamaraj University
Madurai, Tamil Nadu
11.1999

B.Sc - Microbiology

University of Madras
Chennai, Tamil Nadu
04.1997

Skills

  • Project Management
  • Strategic leadership
  • Regulatory Intelligence
  • Analytical Thinking
  • Regulatory Strategy
  • Artificial Intelligence
  • Technical implementation

Certification

  • CERTIFIED LEAD AUDITOR, Completed Lead Auditor course for ISO 13485: 2016 from BSI, ENR-00904280
  • Certified UK Register of Toxicologist, ERT (Cert No: 277981)
  • Completed NSF Certified Course, European Union In-Vitro Diagnostic Device Regulation (IVDR)
  • Certificate from UKNARIC, for M.Sc. Microbiology degree from London
  • Malaysian Institute Medical Laboratory Science, For Biochemistry

Publications

  • Kalyan Kumar.G, Dhamotharan R, Kulkarni NM, Honnegowda S, Murugesan S. Embelin ameliorates dextran sodium sulfate-induced colitis in mice. International Immunopharmacology 11 (2011) 724-731.
  • Kalyan kumar G, Dhamotharan, Nagaraj M. Kulkarni, Mohammad Yunus Mahat, Gunasekaran.J, Mohammad Ashfaque. Embelin reduces cutaneous TNF-α level and ameliorates skin edema in acute and chronic model of skin inflammation in mice, European Journal of Pharmacology 662 (2011) 63-69.
  • Kalyan Kumar G, Dhamotharan R, Vinitha Lakshmi.P and Sujatha Embelin from Embelia ribes suppresses cartilage damage and ameliorates inflammation in an experimental rat adjuvant induced arthritis model. R. ejpmr, 2015,2(3), 441-457.
  • Vinitha Lakshmi, Dhamotharan. R, Kalyan kumar. G Ethnopharmacological approach of Hederagenin isolated from sapindus trifoliatus L. On Non Alcoholic Fatty Liver Disease (NAFLD) associated with type 2 diabetes in C57BL/6 mice . ejpmr, 2015,2(3), 706-718.
  • Lohiny B, Swetha M, Vasantha Kumar T, Kalyan Kumar.G In vitro cytotoxicity and cytogeneticity assay measuring the mutagenicity induced as effect of cell phone radiation. International journal of pharma and biosciences. September 2017 issue expected Impact factor 6.268 (Scopus journal).
  • Prospects of Artificial Intelligence in Medical Devices – Benefits and Challenges Kalyan Kumar Gopal
  • Arulius Savio Pr, Saranya Nidhyanandan, Shyam Sunder Rao Chepuru, Makesh Ramalingam, Manjunath Hadavanahalli Shivarudraia, ijpbs 2022;13.2.b38-47

Awards

  • Nominated and awarded for Best oral presentation by Indian association of biomedicine scientists in the symposium on Bio resources in the development of medicine for the paper In vivo pharmacological evaluation of NSAID and steroidal drugs in Psoriasis model.
  • Institutional Award 2014 for exceptional performance and commitment in work.
  • Best Performer award for HCL Talents (4 Consecutive years).

Personal Information

  • Date of Birth: 01/31/76
  • Nationality: Indian
  • Visa Status: EAD (Green Card)

Timeline

Associate Director – Regulatory affairs

QIAGEN Inc
04.2021 - Current

Senior Manager

Beckton Dickinson
08.2016 - 04.2022

Associate Scientist III – Biocompatibility and Toxicology Studies.

Kemin Industries (Vanta Bioscience)
07.2010 - 08.2016

Research Associate (Preclinical / Safety Pharmacology)

Orchid Research Laboratory Limited
01.2005 - 07.2010

Microbiologist

Minister of Health Malaysia
04.2002 - 09.2005

PhD - Microbiology

University of Madras

MPhil - Biotechnology

Periyar University

M.Sc - Microbiology

Madurai Kamaraj University

B.Sc - Microbiology

University of Madras

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Kalyan Kumar Gopal