Document Control Operations Specialist
Resume:
RACHEL
FRAYSER
*****@*******.***
WWW.LINKEDIN.COM/IN/RACH
EL-FRAYSER-18306532
OBJECTIVE
Meet the needs of the business
promptly without sacrificing
quality.
EDUCATION
Bachelor of Arts
University of Akron
EXPERIENCE
SENIOR REGULATORY OPERATIONS SPECIALIST /
STERIS-CORPORATE (NOV 2021 – APRIL 2024)
• Manage Document Control for AST BU Global Quality Management System
• Completed the FDA annual registration food registration and assisted with medical device registrations.
• Maintain electronic submission documents, shared folders, and databases for accuracy and timely implementation.
• Completed intended-for-use research for products FDA listing requirements.
• Facilitated and mentored co-workers on good documentation practices.
COMPLIANCE ANALYST / STERIS CORPORATE (OCT
2019 - NOV 2021)
• Revised policies and procedures to ensure regulations are relevant and communicated to employees.
• Coordinate and complete the Conflict Minerals report process.
• Completed vigilant report to adhere to FDA and EU MDR regulations.
• Performed international distributors reviews for compliance with anti-bribery and anti-corruption regulations.
FREELANCE WRITER / CLEVELAND CLINIC (2017 -
2019)
• Prepared lay public handouts on medical conditions and tests.
• Authored 40 articles for posted on the Patient Education site. DOCUMENT CONTROL & REGULATORY AFFAIRS
SPECIALIST / STERIS-ENDOSCOPY FACILITY (JULY
2008 – OCT 2019)
• Prepared and trained colleagues on the Change Order work instructions for the change process and label process systems.
• Released documents in hardcopy and electronic format.
• Issued document notifications to personnel.
• Manage label process to ensure accuracy, printability, scan readability, and compliance with regulations.
• Assist with registration documentation of Asia products.
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