Dipika Patel

Review clinical and product complaints to assess reportability in compliance with global medical device regulations. Complete reportability assessments and assist with writing Health Risk Assessments and safety summaries.

Provided regulatory affairs consulting services for medical devices, including non-compliance remediation and regulatory compliance. Led the remediation team on complaints initiation, investigation, and assessments, and trained new team members.

Maintained accurate entry of complaints in database and independently assessed complaints to determine if medical device reports needed to be filed with global regulatory agencies. Worked collaboratively with cross-functional groups on evaluation trends and findings.

Worked as lead coordinator for COPD trials, including consenting subjects, preparing IRB materials, maintaining regulatory binders, and performing study procedures. Handled phlebotomy, specimen collection, and data collection.

Performed blood draws, specimen collection, and medical history documentation for insurance companies.

Worked in the fields of hematology, serology, and urinalysis.

Cared for walk-in patients, performed vitals, EKGs, splinting, and dressing, and triaged phone calls. Assisted physicians with procedures and collected specimens.

Worked with electronic health records, triaged phone calls, performed vitals, EKGs, and assisted with office procedures. Rotated between front and back office, scheduling, and giving immunizations.

Performed vital signs, assisted doctors with small office procedures such as colposcopy, sigmoidoscopy, PAP, ECG, and UA, and assisted patients.

Medical Assistant training at Thompson Institute in Philadelphia, PA.

Post graduate Laboratory Technician program at SMT Institute, Gujarat, India.

Bachelor of Science in Microbiology from Sardar Patel University, Gujarat, India.