Quality Assurance Documentation Specialist

@ Talentify.io

About the Role

The Quality Assurance Documentation Specialist is a fully remote opportunity in the medical device regulatory affairs sector with Talentify.io. You will prepare and update 510(k) submissions and technical files, conduct post-market surveillance, translate design drawings, create hyperlinked documents, and collaborate with internal teams to ensure accurate and timely documentation.

Key Responsibilities

• Prepare and update 510(k) submissions and technical files.
• Conduct post-market surveillance activities including PMCF and PSUR.
• Translate design drawings into accessible documentation.
• Create and manage hyperlinked Word documents.
• Collaborate with teams for accurate documentation.

Qualifications

Experience in medical device regulatory affairs or corporate quality; strong familiarity with 510(k) processes; proficiency in Microsoft Word for hyperlinking and document structuring; ability to summarize scientific literature; and knowledge of QMS, PMCF, and PSUR requirements.

Preferred Qualifications

Experience with SRN number lookup, product stewardship, and pharmaceutical tech file background that can transition into medical device standards.

Key skills/competency

510(k), regulatory, QMS, PMCF, PSUR, documentation, Microsoft Word, hyperlinked documents, surveillance, technical files