EDUCATION

Northeastern University. Boston, MA.

Candidate for Master of Science in Regulatory Affairs January 2017.

Concentration in General Regulatory Affairs, GPA: 3.2 Relevant Courses: New Drug Development, Drug and Medical Device Development, Biologics and Device Development, Medical Device Development, Human experimentation and clinical trials, Strategic Planning and management, European Asian Canadian Regulatory Compliance.

Sophia College. Mumbai, India. Post Graduate Diploma in Clinical Analysis, GPA: 4.5/5.0. August 2016. Relevant Courses: Hematology, Phlebotomy, Biochemistry, Urine Parasitology, Microbiology, Blood Banking. Activities: Participating in Organizing CME (Continuing Medical Education) as a core member of Organizing Committee for the event.

N.K College. Mumbai, India. Bachelors of Science in Microbiology June-2015. Relevant Courses: Chemistry, Genetics, Industrial Microbiology, Food Microbiology.

WORK EXPERIENCE.

MEDTRONIC 15, Hampshire street,

Mansfield, MA

Job Title: Regulatory Affair Specialist July, 2017- Present

Job Responsibilities:

Work on complaints from different parts of the globe like Canada, China, Europe.

To evaluate incoming complaint information and maintains it in the electronic database.

To determine report ability (MDR/AE) of complaints to FDA and other international regulatory agencies.

To work closely with customers and sales representatives to respond to complaint reports.

To closely monitor quality, completeness and timeliness of complaint investigations and files.

To review, analyze on complaint data and escalate issue and trends to Management and other departments as needed.

To work with cross functional teams to ensure proper communication and evaluation/investigation of customer issues.

To participate in team decision making and displays team problem solving/communication skills.

To complies with all health, safety and environmental policies.

CVS PHARMACY. Jamaica Plain, MA. Pharmacy Technician Intern. February 2017- July 2017

Work with the pharmacist and fellow technicians on preparing and giving out prescription medication.

Attend Phone calls and acknowledge question and answer them over phone.

Help at production in counting pills and filling prescription, label an give basic instructions and help take payments.

CUMBALLA HILL HOSPITAL. Mumbai, India. LAB TECHNICIAN. MAY-AUG 2016.

To prepare Blood smears and perform cell counting.

Observe and report Urine Parasitology and Stool slides.

Perform blood collection.

Assist the lead technician in typing blood reports.

SKILLS

LANGUAGE: Fluent in English.

COMPUTER SKILLS: Proficient in M.S word, Power point, Excel and Project.

SPECIAL SKILLS: Skilled in the handling and care of equipment in a microbiological and laboratory.

Skilled in organizing college events and leading a team to a set goal.

Skilled in handling the Biochemistry machines in a pathological laboratory.

Proficient in performing ELISA, AGE, PAGE Techniques Have been on the editorial team of the school magazine. Tutored subjects like Biology, Chemistry, Physics to the high school (class XII) students.

L