Experience

eemagine Medical Imaging Solutions GmbH

• Germany
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Associate Quality Assurance and Regulatory Affairs

  • Feb 2022 - Present

  Quality Assurance:• Support in maintaining and expanding the company’s portfolio of product certifications (e.g. EU MDR 2017/745 transition)• Support in maintaining the company’s ISO 13485 certification status• Maintain the technical documentation of the company's product portfolios• Act as a (lead-) auditor in internal and supplier audits, participate in external audits• Contribute to development projects from QA/RA perspectiveRegulatory Affairs:• Compile technical dossiers for product registrations• Handle the notarisation and legalisation for official documents• Monitor the market for changes in regulatory requirements and ensure compliance (including data privacy)• Manage Usability Validation studies with partners (ISO 62366-1:2015)• Manage the post-market surveillance procedures, contribute from QA/RA perspective

• Assistant Quality Assurance and Regulatory Affairs

  • Jan 2021 - Feb 2022

  Quality Assurance:- Support maintaining and expanding the company's portfolio of product certifications- Support in maintaining the company's ISO certification status- Maintaining technical documentation of the product portfolios- Participating and operating as an auditor in internal and external auditsRegulatory Affairs:- Compiling product dossiers for product registration- Assisting in notarization and legalisation procedures for official documents- Monitoring and ensuring compliance with the changes in the regulatory requirements- Contributing to validation studies for the products- Updating post-market surveillance documentation

• Werkstudent QA/RA Medical Device

  • Dec 2019 - Dec 2020

  Quality Assurance:- Analysing gaps and implementing IEC 62366-1: 2015 with formal updates to documentation- Preparing work instructions for RA (UDI submission to Global Unique Device Identifier Database). - Creating customer survey questionnaires and summarizing customer feedback- Supporting QMD in maintaining the company's ISO certification statusRegulatory Affairs:- Analysing gaps and implementing European Medical Device Regulation 2017/745- Preparing Post-Market Surveillance Documentation- Preparing product submission (MDL registration in Canada)Master Thesis: Optimal Product Lifecycle Management (post-market regulatory requirements)- Compiling, analysing and comparing post-market regulatory requirements of EU, Australia, Brazil, Canada, China, India, Indonesia, Israel, Japan, KSA, Kuwait, Malaysia, Republic of Korea, Russia, Taiwan, Thailand, Turkey, UAE, UK and USA.- Optimizing customer claims categories in the company's ERP system for trend detection- Verifying the legitimacy of the distributors' PMS and vigilance procedure appropriate to their national regulatory requirements.- Updating the relevant workflow procedures based on gaps identified.



Innov4Sight Health and Biomedical Systems Private Limited

• India
• Machinery Manufacturing

• Apprentice in Clinical Research Department

  • Jul 2017 - Jul 2018

  Worked as an intern in Therostics department, dealing with Fertility solutions. Where I worked as a part of a cross-functional team in study and documentation of multicentre, multicity randomized Clinical Trials of minimally manipulated autologous Blood Derived product under the National Guidelines for Stem Cell Research, ICMR.My responsibilities also involved:• Patient on-boarding factoring Inclusion and Exclusion Trials• Anonymization of Patient DATA• Follow up with Clinics and Patients

• Management Trainee

  • Jun 2016 - May 2017

  Worked with data analytics platform for oncology, ParSight, that aggregates information on cancer patients for research. I was involved in interactions with Clinical partners on Cancer diagnosis and co-ordination of second opinion in Cancer care. Worked with data analytics platform for oncology, ParSight, that aggregates information on cancer patients for research. I was involved in interactions with Clinical partners on Cancer diagnosis and co-ordination of second opinion in Cancer care.



Board Of Radiation & Isotope Technology

• India
• 1 - 100 Employee

• Project Intern

  • Jun 2015 - Apr 2016

  Worked on the study and modification of 99Mo/ 99mTc generator (a device widely used for transportation of radioactive Technetium for diagnostic purpose in Nuclear Medicine) to make it efficient and cost effective with the use of bio-adsorbent. I could establish an interdisciplinary interface between Biotechnology and Radiopharmaceuticals by applying various techniques in my project that I had learnt in my undergraduate studies. This project also gave me an opportunity to learn new things and operate on equipment apart from those I had handled in the college laboratories such as:- Solvent extraction for purification of Sodium pertechnate using Methyl ethyl ketone- Used Radiochromatogram scanner to test Mo-99 retention- Used High-Purity Germanium Detector for analysing purity of Sodium pertectnate