MOHAMMED IBRAHIM ABDUL ROUF
Cork,Ireland
Summary
Driven professional with keen ability to interpret regulations and ensure compliance. Demonstrates strong analytical skills and effective communication in managing regulatory documentation and liaising with stakeholders. Aims to ensure seamless regulatory approval processes, contributing to success of organisation.
Overview
6
6
years of professional experience
2023
2023
years of post-secondary education
Work History
Student Intern
Pfizer Healthcare India Private Limited
Chennai
12.2018
- Gained practical knowledge in both the Research and Development and Process Safety Lab
- Gained knowledge on how to work in an industrial
Student Intern
Meenakshi Mission Hospitals and Research Center
Madurai, India
01.2016
- Closely observed all the medical equipment
Biomedical Engineer Intern
Apollo Hospitals
05.2019 - 08.2019
- Aided in the calibration of medical instruments like infusion pumps, ventilators, defibrillators, and so on
- Helped with preventive maintenance for medical equipment by performing EST and SST
- Worked closely with critical and semi-critical appliances
- Participated in the department audit
- Trained the new interns
Regulatory Affairs Intern
Medtronic
Galway
08.2021 - 07.2022
- Coordinated with International Regulatory Affairs team and Change order cell
- Supported MDD Renewal, Registration, Tenders
- MDR Product Registration and Renewals
- Created Certificate of Analysis for medical device
- Monitored and improved data capture system
- Identified and developed best procedures within the Regulatory Affairs Department, including approaches for continuous development
Associate Regulatory Affairs Specialist
Medtronic
Galway
07.2022 - 03.2025
Regulatory affairs specialist
Medtronic
Galway, County Galway
07.2024 - Current
- Interpreted new regulations and policies for their implementation within the company's framework.
- Established effective communication with regulatory bodies, ensuring transparency in operations.
- Conducted comprehensive audits to ensure compliance with regulations and standards.
- Supported departmental objectives by maintaining a strong working relationship with stakeholders both internally and externally.
- Developed regulatory strategies to facilitate successful product registrations.
- Maintained regulatory files and authorisations to enable reporting and renewal.
- Achieved streamlined reporting processes by developing efficient documentation procedures.
Education
Master of Science - Biomedical Science
National University of Ireland
Bachelor of Technology - Biomedical engineering
Sathayabama Institute of science and technology
Skills
- Leadership
- Presentation
- Computing
- Communication
- Team Work
- GMP awareness
- EU mdr compliance
- Medical device regulation familiarity
- Regulatory submissions experience
- Change management proficiency
- Stakeholder management competency
Additional Information
Organized a women empowerment camp on women's day at Sathyabama Institute of Science and Technology., Organized a safety awareness camp at Sathyabama Institute of Science and Technology., Have organized an organ donation camp with over 200 donors.
Custom
Runner up in the Techno Vision Competition conducted by Sathyabama University.
Timeline
Regulatory affairs specialist
Medtronic
07.2024 - Current
Associate Regulatory Affairs Specialist
Medtronic
07.2022 - 03.2025
Regulatory Affairs Intern
Medtronic
08.2021 - 07.2022
Biomedical Engineer Intern
Apollo Hospitals
05.2019 - 08.2019
Student Intern
Pfizer Healthcare India Private Limited
12.2018
Student Intern
Meenakshi Mission Hospitals and Research Center
01.2016
Bachelor of Technology - Biomedical engineering
Sathayabama Institute of science and technology
Master of Science - Biomedical Science
National University of Ireland
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