Sharika Aravinth
Ireland
Summary
Biomedical Engineer applying for the role of Regulatory Affairs Specialist. Currently completing a final internship at Badalona Serveis Assistencials under the supervision of Dr. José Ferrer Costa and graduating from an engineering institution specialising in Medical Devices. Hands-on experience evaluating Class III devices, managing device classifications under EU MDR 2017/745, and participating in internal quality audits following ISO 13485. Fully bilingual in English and French, with intermediate proficiency in Spanish.
Overview
8
8
years of professional experience
5
5
years of post-secondary education
1
1
Certification
Work history
Biomedical Engineer Intern – Regulatory Affairs
Badalona Serveis Assistencials
Badalona
2026.04 - Current
- Worked under the supervision of Dr. José Ferrer Costa on regulatory affairs and medical device classification projects.
- Evaluated whether products qualified as wellness devices, accessories, or medical devices in accordance with EU MDR 2017/745.
- Classified medical devices and VR software under MDR regulatory requirements.
- Assisted patients with the use of VR rehabilitation software.
- Supported regulatory compliance activities within a clinical environment.
- Currently creating technical documentation on software for training purposes.
Biomedical Engineering Student – Research and Development
CTB-UPM (Center for Biomedical Technology)
Madrid
2025.12 - 2026.03
- Developed a program enabling connectivity, through Bluetooth, of IMU sensors to detect the movement and environment surrounding newborn babies in a hospital.
- Completed the handover of the prototype in Spanish and in English before departure.
Biomedical Engineering Student – Regulatory Affairs
ISIFC - Biotika
Besançon
2025.03 - 2025.06
- Supported regulatory affairs activities for medical devices under development.
- Collaborated with R&D engineers and the Project Manager to track the evolution of medical devices and accessories.
- Initiated technical documentation for various medical devices in multiple projects.
- Participated in an internal audit as an auditor to enforce ISO 13485, perform non-conformance investigations and support corrective processes.
- Authored in the final school project a technical documentation focusing on technical risks on the Class III HiRes Ultra 3D cochlear implant, evaluating biocompatibility, risks, regulatory labelling.
Biomedical Intern – Radiophysics & Radioprotection
Hospital Center of Princess Grace
2025.01 - 2025.02
- Conducted output measurements and time-duration verifications on the Xstrahl 100 system to verify the precise radiation release levels.
- Assisted the radiophysics team in calibrating equipment parameters.
- Maintained detailed records of radiation measurements to monitor system consistency.
Chair – FERMUN (Model United Nations)
City School International De Ferney-Voltaire
Geneva
2018.07 - 2019.01
- Collaborated in months of preparation in France for the debates leading up to the official MUN conference in Geneva, Switzerland.
- Chaired a committee on Sustainable Communities.
- Delivered the closing ceremony speech in front of over 700 students.
Education
Master’s - Biomedical Engineering – Specialisation in Medical Devices and Regulatory Affairs
ISIFC (Higher Institute of Engineers of Franche-Comté)
Besançon, France 2022.09 -
ERASMUS Master’s - Biomedical Engineering
UPM - ETSIT (UPM Higher Technical School of Engineers in Telecommunication)
Madrid, Spain 2025.09 - 2026.01
Preparatory Class for Engineering Schools - Industrial Engineering
Lycée Jules Ferry
Cannes, France 2021.09 - 2022.07
Technical Diploma - Electrical Engineering & Industrial Computing
University Institute of Technology Nice Côte d’Azur
Nice, France 2019.09 - 2021.06
International Baccalaureate - Cambridge International Examinations
Fénelon Institute
Grasse, France 2017.09 - 2019.06
Skills
- EU MDR 2017/745
- Experience with ISO 13485
- Experience with ISO 14971 annex and ISO TR 24971
- Technical documentation and regulatory affairs fundamentals
- Basic knowledge of the MDD to MDR transition timeline
- Radiophysics & Radioprotection
- Electronic card fabrication and robot circuit design using DesignSpark
- Programming languages: C, C, Java, and HTML
Websites
LANGUAGES
English: Native + TOEIC: 970/990
Fluent
French: Native
Fluent
Spanish: Intermediate
Intermediate
Tamil: Basic
Beginner
INTERESTS & ACTIVITIES
Piano — 10 years of conservatory training, awarded the Certificate of Musical Studies (Intermediate Level), Electric Guitar, Judo, Crochet, Competitive Archery
PROJECTS & ADDITIONAL EXPERIENCE
- Prepared a complete technical documentation on a Class III Medical Device.
- Participated as an auditor in an internal audit conducted at Biotika.
Affiliations
- • Piano — 10 years of conservatory training, awarded the Certificate of Musical Studies (Intermediate Level)
- • Judo
- • Crochet
- • Competitive Archery
Certification
TOEIC with a score of 970/990
Timeline
Biomedical Engineer Intern – Regulatory Affairs
Badalona Serveis Assistencials
2026.04 - Current
Biomedical Engineering Student – Research and Development
CTB-UPM (Center for Biomedical Technology)
2025.12 - 2026.03
ERASMUS Master’s - Biomedical Engineering
UPM - ETSIT (UPM Higher Technical School of Engineers in Telecommunication)
2025.09 - 2026.01
Biomedical Engineering Student – Regulatory Affairs
ISIFC - Biotika
2025.03 - 2025.06
Biomedical Intern – Radiophysics & Radioprotection
Hospital Center of Princess Grace
2025.01 - 2025.02
Master’s - Biomedical Engineering – Specialisation in Medical Devices and Regulatory Affairs
ISIFC (Higher Institute of Engineers of Franche-Comté)
2022.09 -
Preparatory Class for Engineering Schools - Industrial Engineering
Lycée Jules Ferry
2021.09 - 2022.07
Technical Diploma - Electrical Engineering & Industrial Computing
University Institute of Technology Nice Côte d’Azur
2019.09 - 2021.06
Chair – FERMUN (Model United Nations)
City School International De Ferney-Voltaire
2018.07 - 2019.01
International Baccalaureate - Cambridge International Examinations
Fénelon Institute
2017.09 - 2019.06