Sruthy Salimkumar
Kilkenny,Kilkenny
Summary
Detailed-oriented Msc Regulatory Affairs graduate with hands-on laboratory experience and strong knowledge of GMP,EU MDR,ISO 13485, and quality management systems. Experienced in maintaining compliance, accurate documentation, and supporting risk management activities in regulated environments. Adapt at working in fast-paced settings while ensuring high standards of safety, quality, and regulatory adherence. Seeking to contribute to a quality-driven medical device or pharmaceutical organization.
Overview
3
3
years of professional experience
Work history
Sales assistant
Dunnes Stores
Kilkenny, Ireland
2024.11 - Current
- Delivered high-quality customer service in fast-paced retail environment.
- Handled customer complaints and resolved issues efficiently.
- Maintained accurate stock records and pricing updates.
- Followed company procedures and compliance standards.
Lab assistant
Sree Narayana College of Teacher Education
Palakkad, India
2022.11 - 2024.08
- Ensured compliance with laboratory SOPs and quality control procedures.
- Performed equipment calibration in line with documented standards.
- Maintained accurate experimental records following GDP.
- Assisted in audit readiness by organizing records and documentation.
Education
Master of Science - Regulatory Affairs
South East Technological University
Carlow, Ireland /2024 - /2025
Master of Science - Physics
St. Xavier's Women's College
Aluva, India /2020 - /2022
Bachelor of Science - Physics
Pavanatma College
Murickassery,India /2017 - /2020
Skills
Laboratory Skills
- Laboratory equipment handling
- Aseptic technique and lab safety procedures
- Accurate data recording and report preparation
Quality and Compliance
- cGMP, cGLP, GDP, Data Integrity
- QA documentation and batch records
- QMS,LIMS documentation
- CAPA, deviations, audit participation
- Equipment qualification and calibration
- Risk assessments, hazard identification
Regulatory Affairs
- EU MDR and FDA regulatory pathways
- Technical file preparation and documentation
- labeling, UID, Vigilance, and PMS requirements
- SOP writing, protocol creation, method transfers
Computer Skills
- MS office
- MS Excel
- MS power point
Soft Skills
- Communication and teamwork
- Attention to detail
- Analytical thinking
- Safety awareness
- Ability to work independently and in cross-functional teams
Projects
Comparative Analysis: Medical Device Regulations of Compliance and Enforcement in The US and Canada
South East Technological University, Carlow, Ireland
- Analyzed FDA 510(k), PMA pathways and EU MDR classification systems.
- Compared compliance and enforcement frameworks.
- Evaluated impact of Regulatory differences on manufactures.
- Studied post-market surveillance and quality system requirements.
- Assessed alignment with ISO 13485 and quality system requirements.
Languages
English
Fluent
Malayalam
Native
Tamil
Fluent
Hindi
Intermediate
Work Eligiblity
Stamp1G Visa Holder -Eligible to work full-time (40 hours/week)
Rferences
Available upon request
Timeline
Sales assistant
Dunnes Stores
2024.11 - Current
Lab assistant
Sree Narayana College of Teacher Education
2022.11 - 2024.08
Master of Science - Regulatory Affairs
South East Technological University
/2024 - /2025
Master of Science - Physics
St. Xavier's Women's College
/2020 - /2022
Bachelor of Science - Physics
Pavanatma College
/2017 - /2020