AZIM U.

PHONE: (215)436-9492 | EMAIL: AZIM_10DH@YAHOO.com

Certified project management and regulatory affairs professional with a combined 8-year experience in
medical device and pharmaceutical post-market surveillance. Extensive knowledge in applying quality
management system to support overall product life cycle management. Successfully managed over 50
field safety corrective actions thru completion across multiple product lines.

EDUCATION
BS Materials Science & Engineering Pennsylvania State University - University Park, PA

CERTIFICATION
Project Management Professional (PMP) Project Management Institute - Newtown Square, PA

PROFESSIONAL EXPERIENCE

Project Manager – EU MDR Post-Market Surveillance Integration Dec’19 to Present

• Develop Post-Market Surveillance Templates including PMS Plan, PMSR and PSUR Templates for
ABPHINA.

• Perform Post-Market Surveillance system audits against EU MDR Post-Market Surveillance

requirements.

• Support PMS Procedures and Technical Documents updates for ABPHINA clients to meet the
requirements of EU MDR.

• Support ABPHINA clients identify appropriate sources of PMS data and determine appropriate
PMS review frequency.

• Analyze Clinical and Post Market Surveillance data as it pertains to the device risk-benefit
analysis profile.

• Work with cross-functional team (Engineering, Clinical Affairs, Quality, and Regulatory
Marketing, to update risk management following Post Market Surveillance data review.

Tosoh Bioscience Inc. – Project Manager, Recall Remediation Columbus, OH Jul’18 to Jan’19

 Facilitated Quality Review Board meetings to escalate quality event to recall decision.
 Reviewed retrospective records to identify correction and removal per FDA 21CFR Part 806.
 Developed Health Hazard Evaluations for 806 reporting and managed Customer Communication
across multiple sites.
 Served as Subject Matter Expert for Recall during FDA audit under Warning Letter.
 Facilitated recall related CAPA activities for successful closure.

CooperSurgical Inc. – Field Actions Specialist Trumbull, CT Aug ‘14 to Jul’18

 Initiated and managed Medical Device Recalls

 Managed risk by identifying product safety issues requiring further investigation
 Prepared and submitted Recall notification documents to the FDA and other Regulatory Bodies

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 AZIM U.
PHONE: (215)436-9492 | EMAIL: AZIM_10DH@YAHOO.com

 Reviewed and evaluated complaints for MDR reportable per FDA 21CFR part 803
 Ensure timely complaint handling and adverse events reporting via Electronic Submission
 Identify any quality or compliance concerns and take immediate corrective action as required
 Analyzed distribution and complaints record from bulk data
 Prepared technical and summary reports for internal and external stakeholders
 Cross Trained new hires and other department staff on post-market surveillance procedure

Accupac Inc – Quality Assurance Mainland, PA Sep ‘11 to Jan ‘14

 Key Support for Product Complaint, Product Reviews, and Stability Testing
 Performed product batch record, specifications and drawing reviews as needed
 Created Standard Operation Procedure for test methods and equipment operation
 Generated Material Assay Report to be tested to confirm component specification
 Sampled Raw Material following MSDS per SOPs and CFR 21 Part 211
 Scheduled components inspection to reduce two years of backlog

Penn State - Research Assistant University Park Aug ‘07 to May ‘08

 Fabricated polymer nanofibers using ‘Jet Blowing' method to be used as a cell host
 Constructed experiments and analyzed data of all results to reach a conclusion
 Collaborated to redesign the gas chamber to prevent loss of pressure and improve performance

TECHNICAL SKILLS
Regulatory: eMDR submission | Medical Device Recall | Vigilance | Health Canada MDR | EU MDR
Quality: SOP | cGMP | Quality System | CAPA | Validation | APR | Trending
Coatings: Chemical Vapor Deposition | Sputtering | Wafer Oxidation | Lithography | Etching
Characterization: Scanning Electron Microscopy | Optical Microscopy
Software: SAP Business Objects| MasterControl| Mathematica | MATLAB | C++ | Accuterm | Dataworks

CAPSTONE PROJECT
Performance of Chemical Binders for Dust and Erosion Control in Road Construction, Bayer Material
Science (1st Place at Learning Factory showcase)

 Explored dust palliatives and soil stabilizer currently used in the market
 Built erosion control test apparatus with rain simulator according to ASTM standard
 Tested products for erosion, compression, and percolation to determine the viability of Bayer's
latex resin to compete with the existing product

PROFESSIONAL AFFILIATIONS
Material Advantage, MA
American Society for Quality, ASQ
Project Management Institute, PMI
Regulatory Affairs Professionals Society, RAPS

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