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Pearl A
@pearl_aders
ISO Compliance and Regulatory Documentation Specialist
Vereinigte Staaten
Englisch
Über mich
Hi, I'm Pearl, an ISO Compliance & Quality Management Consultant specializing in certification-ready documentation for businesses worldwide. I develop customized QMS, SOPs, policies, procedures, risk assessments, CAPA, GMP, and regulatory documentation aligned with ISO 9001, ISO 13485, ISO 22000, FSSC 22000, BRC, IFS, ISO 27001, ISO 45001, and related standards. Whether you're implementing a new management system or preparing for certification, I deliver practical, audit-ready documentation tailored to your operations with professionalism, accuracy, and confidentiality.
Kompetenzen
Pearl A
offline •
Durchschnittliche Antwortzeit: 1 Stunde
Meine Dienstleistungen
Projektmanagement
I will prepare iso 9001 qms, iso 27001, iso 45001 and gmp documentation
Regulierung für Medizinprodukte
I will prepare iso 13485 qms, sops and medical device documentation
Portfolio
Arbeitserfahrung
Medical Device Regulatory Specialist
Food and Agriculture Organization of the United Nations • Vollzeit
Jun 2022 - Present • 4 yrs 2 mos
Supported medical device manufacturers through FDA regulatory processes including 510(k) preparation, device classification, predicate research, establishment registration, GUDID submissions, device listing, regulatory documentation review, labeling compliance, and post-market regulatory support. Assisted clients in preparing complete submission packages aligned with FDA expectations.
Federal Procurement & Grant Advisory Services | United States
Procurement Tactics • Freiberufler
Jan 2022 - Present • 4 yrs 7 mos
Specialized in government contract bid proposals, RFP responses, RFQ submissions, capability statements, SAM.gov registration support, and procurement consulting for startups, small businesses, nonprofits, and contractors seeking federal, state, and local contract opportunities.
Strategic Funding Solutions | United States
Small Business Administration • Freiberufler
Jun 2021 - Present • 5 yrs 2 mos
Provided grant proposal writing, grant research, nonprofit funding support, SBIR grant assistance, and business funding consulting for nonprofits, startups, educational organizations, and small businesses pursuing government and private funding opportunities.
