Regulatory & Quality Assurance Specialist Resume

SUMMARY

Former regulatory and quality assurance specialist prompting a direct transition into regulatory affairs. Eager to leverage my prior regulatory affairs internship experience and technical knowledge regarding international regulatory regulations along with my passion for the highly regulated medical device industry to secure an entry - level Regulatory Affairs position.

TECHNICAL SKILLS

PROFESSIONAL EXPERIENCE

Regulatory & Quality Assurance Specialist

Confidential

Responsibilities:

Implemented Agile methodology (Kanban, stand-up) to organize quality team which resulted in a 37% increase in the on-time testing metric for North America distributed Confidential products.
Reinforced 5S weekly audits in manufacturing which decreased operator errors by 72% in Q4.
Improved inventory control accuracy by 24% through implementing SQL to extract critical materials from SAP.
Participate in CAPAs, risk assessment, design dossiers and regulatory submissions for global products.
Manage ASTM certified QA testing on all globally distributed products following GMP and GDP practices.

Regulatory Affairs Intern

Confidential

Responsibilities:

Collaborated with different departments to update and maintain controlled documentation (e.g., Device History Record, Summary Technical Documentation-STED, IVDR Technical Documentation, Clinical Evaluation Reports, Sterilization reports, pFMEA, Risk Assessment, Design Dossier) for compliance with FDA and ISO regulations.
Planned, prepared, and reviewed required technical documentation of new or modified medical devices for use in regulatory submissions worldwide (e.g., CE Technical files, 510k submissions, Certificate to Foreign Government, International Regulatory Requests, Medical Device History Reports, Certificate of Free Sale).

Assistant Manager

Confidential

Responsibilities:

Analyzed raw ingredient prices from 12 local vendors to purchase items with the highest quality per price ratio which saved $32,200 annually.
Increase food completion rate by 47% during peak hours by implementing Kanban to organize priority.
Resolve conflicts with unsatisfied customers by providing a professional and suitable compromise.
Reached out to 51 dissatisfied customers on Google Reviews increasing the overall rating from 3.7 stars to 4.3.