SAFNA KUYYALIL
Summary
Results-driven and detail-oriented Regulatory Affairs Specialist with expertise in the medical device and pharmaceutical industry in Bahrain. Possesses a comprehensive understanding of local and international regulations, coupled with the ability to effectively manage regulatory submissions, maintain product registrations, and develop regulatory strategies. Keeps abreast of emerging trends and changes in the medical device industry, providing valuable insights and regulatory intelligence to stakeholders. Skilled in effectively communicating with regulatory authorities and responding to inquiries to ensure smooth interactions and compliance.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Officer
Gmedco Medical Company W.L.L.
09.2023 - Current
- Verification of quality documents & Submission of import permit application Medical Device Authorized Representative Renewal, and Variation Medical Device Classification and Evaluation Medical Device Registration, Renewal, and Variation Quality Assurance
Regulatory Affairs Specialist
Assure Healthcare Consulting
07.2022 - 09.2023
- Medical Device Authorized Representative Registration, Renewal, and Variation Medical Device Classification and Evaluation Medical Device Registration, Renewal, and Variation Pharmaceutical Product Classification, Registration, Renewal, and Variation under supervision
Patient Care
Shifa Budaiya Medical Center
04.2022 - 07.2022
- Provide basic care to the patient
- Take care of patient's needs whether they are in hospital, observation room or nursing station
- Guide patients and bystanders to the respective physicians and other departments Answered patient assistance calls, assessed needs, and offered qualified support
- Collected and transported specimens to prepare for lab testing
- Responded to patient emergencies with immediate care and notified clinicians to provide comprehensive assistance
- Obtained patient vital signs and reported results to staff nurse or physician, noting changes from prior measurements.
Registered Pharmacist
Puthukkidiyil Medical Centre
04.2021 - 04.2022
- Prescription Filling and Dispensing Inventory Management and Reporting Shelf Stocking and Organization Prescription Review and Documentation Patient Education and Counseling
Trainee Pharmacist
Government Medical College
09.2020 - 01.2021
- Dispensed Prescription under supervision Assisted registered pharmacist
- Inventory management
- Continuous learning and development
Education
Bachelor of Pharmacy -
Govt Medical College, Trivandrum
04.2021
Higher Secondary Education -
RAC HSS Katameri
01.2015
Secondary Education -
MET Public School
01.2013
Skills
- Regulatory Compliance
- Data Verification
- Import Permit Applications
- Product Classification
- Product Registration
- Regulatory Liaison
- Regulatory Intelligence
- Cross-functional Collaboration
Certification
National Health Regulatory Authority (NHRA) Medical Device Regulation Training, 09/2023, Completed training program on medical device regulation provided by NHRA.
Attained Regulatory Affairs Certificate with outstanding performance, achieving a score of 96% on the certification examination.
Timeline
Regulatory Affairs Officer
Gmedco Medical Company W.L.L.
09.2023 - Current
Regulatory Affairs Specialist
Assure Healthcare Consulting
07.2022 - 09.2023
Patient Care
Shifa Budaiya Medical Center
04.2022 - 07.2022
Registered Pharmacist
Puthukkidiyil Medical Centre
04.2021 - 04.2022
Trainee Pharmacist
Government Medical College
09.2020 - 01.2021
Bachelor of Pharmacy -
Govt Medical College, Trivandrum
Higher Secondary Education -
RAC HSS Katameri
Secondary Education -
MET Public School
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