TARUN KUMAR
Delhi
Summary
Aspiring to cultivate a dynamic and challenging career focused on contributing expertise and skills to enhance organizational performance through ongoing learning and teamwork.
Overview
1
1
Language
1
1
Certification
7
7
years of professional experience
Work History
Regulatory Affair Executive
Auxein Medical Private Ltd.
05.2022 - Current
- Experienced in the registration and regulatory compliance of orthopedic implants under Regulation (EU) 2017/745 (EU MDR).
- Participated in and supported MDR device registration audits, including preparation and presentation of relevant regulatory and technical documentation.
- Participated in QMS surveillance audits and audits conducted by Notified Bodies, including coordination of required records and responses to audit observations.
- Prepared regulatory dossiers and supporting technical documentation for medical-device submissions.
- Prepared Device Descriptions and related technical documentation, with approximately 4 years of experience.
- Prepared Clinical Evaluation Reports (CERs) in accordance with applicable EU MDR requirements, with approximately 3 years of experience.
- Prepared Summary of Safety and Clinical Performance (SSCP) documents for medical-device submissions, with approximately 3 years of experience.
- Prepared Post-Market Clinical Follow-up (PMCF) Reports and related documentation, with approximately 2 years of experience.
- Prepared and reviewed Risk Management Reports and associated risk-management documentation, with approximately 1.5 years of experience.
- Coordinated the compilation, review, and maintenance of regulatory documentation to support product registration and conformity-assessment activities.
- Supported the preparation of technical files, clinical documentation, and audit responses in coordination with relevant internal departments.
- Experienced in preparing US FDA 510(k) submission dossiers for orthopedic implants and associated medical devices, in accordance with applicable US FDA regulatory requirements.
- Prepared and compiled Traditional 510(k) submission documentation, including device description, indications for use, substantial equivalence, technological characteristics, performance testing, biocompatibility, sterilization, labeling, and other applicable regulatory requirements.
- Respond to queries as they arise, and ensure that registration/ approval is granted without delay.
Assistant Professor
Hindu College of Pharmacy.
03.2021 - 05.2022
- Research for the current upgoing modification in Pharmacology.
- Designing, Planning lectures of the course work and implementing them for the assigned classes.
- Interaction & Resolving problems of their subjects.
- Developing Interpersonal skills and implementation.
- Attending staff meeting regarding the inspection and necessary approaches for the students.
- Assessing regularly student's work.
Assistant Professor
South Point College of Pharmacy.
01.2020 - 03.2021
- Research for the current upgoing modification in Pharmacology.
- Designing, Planning lectures of the course work and implementing them for the assigned classes.
- Interaction & Resolving problems of their subjects.
- Developing Interpersonal skills and implementation.
- Attending staff meeting regarding the inspection and necessary approaches for the students.
- Assessing regularly student's work.
Education
M.Pharm - Pharmacology
Amity University
Noida01-2019
B.Pharm -
Amity University
Noida01-2017
12th Grade -
Shri Ram Shiksha Mandir
Delhi01-2013
10th Grade -
Shri Ram Shiksha Mandir
Delhi01-2011
Skills
- EU MDR 2017/745 & USFDA 510(k) Compliance
- Regulatory Documentation (SSCP, CER, IFU, DoC, PSUR, GSPR)
- International Dossier Submissions
- SOP Development & Regulatory Strategy
- Clinical Evaluation & Risk Management
- Audit Readiness & Regulatory Inspections
- Cross-functional Collaboration
- Compliance Monitoring & Legal Interpretation
Languages
Languages: English, Hindi, Basic German
PUBLICATIONS
- - Radius Bone Plate Efficacy – IJORO
- - Fibula Fracture Clinical Outcomes – IJORO
- - Humerus Plate Fixation Study – IJORO
- - Tibia Plate System Performance – IJORO
- - Drug Targets for Epilepsy – AJPP
- Protective Effect of Pterocarpus marsupium in Epileptic Rat Models
- - Conducted HPLC and phytochemical screening.
- - Evaluated cognitive impairment and oxidative stress in PTZ-induced seizure models.
- - Innovation Symposium – Amity University, 2018
- - Poster Presentation – IHPA Conference, 2018
- - Volunteer – IPGA Symposium
ADDITIONAL ENGAGEMENTS
- - President – School Government
- - Sports – Zonal & Inter-zonal Level
- - University Sports Team Member
- - Community Outreach Program Completion
Custom
09.07.2025
Certification
- Introduction to EU MDR 2017/745 – Medical Device HQ, - Clinical Pharmacist Internship – Maharaja Agrasen Hospital, Delhi, - Industrial Training – Pure & Cure Healthcare Pvt. Ltd., Haridwar
Timeline
Regulatory Affair Executive
Auxein Medical Private Ltd.
05.2022 - Current
Assistant Professor
Hindu College of Pharmacy.
03.2021 - 05.2022
Assistant Professor
South Point College of Pharmacy.
01.2020 - 03.2021
M.Pharm - Pharmacology
Amity University
B.Pharm -
Amity University
12th Grade -
Shri Ram Shiksha Mandir
10th Grade -
Shri Ram Shiksha Mandir