Iman Mohamed

Analyze product complaints and make critical judgments on reportability of adverse events to global regulators (e.g., FDA, European Competent Authorities) .
Collaborate with cross-functional teams to obtain information necessary for regulatory communications regarding post-market products and adverse event reporting.
Thorough knowledge of FDA and EU regulations along with 510(K) and PMA process, IDE devices, and CE marking.
EU MDR experience.
Through knowledge and experience with class I, II, and III devices
Actively contribute to continual process improvements to adverse event reporting and risk assessments.
Training lead and provide training per regulation requirements to global complaints database users, cross-functional teams and new employee training.
Participated in audit support
In the process of NCR training for CAPA ownership
Perform regular quality review of complaints and work of co-worker for quality assurance purposes.
Assisted in mitigation projects in order to increase the quality of the tasks being completed.

Performed audits of manufacturing lines.
Ensured current SOPs and documentation records are utilized and GMP compliant.
Ensured test results meet current specifications prior to completion.
Documented OOS situations and determine root cause.
Maintained compliance with current regulatory expectations and practices ( e.g USP).
Maintained culture of “lean action” and 5-S in all aspects of the department.

Organized and processed biological specimens following standard operating procedures (SOP) in a fast paced environment.
Obtained and communicated lab test results thoroughly and accurately
Urgently processed STAT add-on tests ordered by physicians, nurses, physician assistants, or laboratory personnel.
Set up blood samples for tests such as HIV, HCV, HBV, Lyme disease, liver function, and allergy testing to be run.
Accurately prepared stool and urine samples for the microbiology department by streaking the samples in different plates to select for different types of bacteria/organisms.

Administered bedside or personal care, such as ambulation, personal hygiene assistance, and medications.
Reported and maintained records of client progress and services performed, reporting changes in client condition to manager or supervisor.

Investigate complaints/events in a timely manner
Assess complaints to determine if a report needs to be filed with various global regulatory agencies
Communicate verbally and in writing with internal and external personnel
Make sound decisions regarding medical device reporting
Thorough knowledge of FDA and EU regulations
Identify inconsistent complaint trends and provide appropriate re-training
Work collaboratively with cross-functional groups and team mates

Performed audits of manufacturing lines
Ensured current SOPs and documentation records are utilized and GMP compliant
Ensured test results meet current specifications prior to completion
Documented OOS situations and determine root cause
Maintained compliance with current regulatory expectations and practices
Maintained culture of 'lean action' and 5-S in all aspects of the department

Organized and processed biological specimens following standard operating procedures
Obtained and communicated lab test results thoroughly and accurately
Urgently processed STAT add-on tests ordered by healthcare professionals
Prepared samples for various tests such as HIV, HCV, HBV, etc.
Prepared stool and urine samples for microbiology department

Analyze product complaints and make critical judgments on reportability of adverse events to global regulators (e.g., FDA, European Competent Authorities and Health Canada).
Collaborate with cross-functional teams to obtain information necessary for regulatory communications regarding post-market products and adverse event reporting.
Thorough knowledge of FDA and EU regulations along with 510(K) and PMA process, IDE devices, and CE marking.
EU MDR experience.
Thorough knowledge and experience with class I, II, and III devices
Actively contribute to continual process improvements to adverse event reporting and risk assessments.
Training lead and provide training per regulation requirements to global complaints database users, cross-functional teams and new employee training.
Participated in audit support
In the process of NCR training for CAPA ownership
Perform regular quality review of complaints and work of co-worker for quality assurance purposes.
Assisted in mitigation projects in order to increase the quality of the tasks being completed.

Investigate complaints/events in a timely manner.
Independently assess the complaint to determine if a report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities).
Communicate verbally and in writing with both internal and external personnel (e.g. physicians, hospital personnel, sales representatives, international offices)
Able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
Thorough knowledge of FDA and EU regulations along with 510(K) and PMA process, IDE devices, and CE marking.
Thorough in identifying inconsistent complaint trends and providing the appropriate re-training
Works collaboratively with cross-functional groups and team mates.

Investigate complaints/events in a timely manner.
Independently assess the complaint to determine if a report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities and Health Canada Experience ) .
Communicate verbally and in writing with both internal and external personnel (e.g. physicians, hospital personnel, sales representatives, international offices)
Able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
Thorough knowledge of FDA and EU regulations along with 510(K) and PMA process, IDE devices, and CE marking.
Through knowledge and experience with class I, II, and III devices.
Thorough in identifying inconsistent complaint trends and providing the appropriate re-training
Works collaboratively with cross-functional groups and team mates.

Performed audits of manufacturing lines.
Ensured current SOPs and documentation records are utilized and GMP compliant.
Ensured test results meet current specifications prior to completion.
Documented OOS situations and determine root cause.
Maintained compliance with current regulatory expectations and practices ( e.g USP).
Maintained culture of “lean action” and 5-S in all aspects of the department.

Organized and processed biological specimens following standard operating procedures (SOP) in a fast paced environment.
Obtained and communicated lab test results thoroughly and accurately
Urgently processed STAT add-on tests ordered by physicians, nurses, physician assistants, or laboratory personnel.
Set up blood samples for tests such as HIV, HCV, HBV, Lyme disease, liver function, and allergy testing to be run.
Accurately prepared stool and urine samples for the microbiology department by streaking the samples in different plates to select for different types of bacteria/organisms.

Administered bedside or personal care, such as ambulation, personal hygiene assistance, and medications.
Reported and maintained records of client progress and services performed, reporting changes in client condition to manager or supervisor.