Remote QA Documentation Specialist, Medical Device

@ Talentify.io

Why Consider This Job Opportunity

Salary up to $40.00/hr, comprehensive benefits including medical, dental, vision, and life insurance, 401(k) retirement plan with pre-tax and Roth contributions available, fully remote position offering flexibility, opportunity for extensive training in documentation and quality management systems, and work with a dedicated team in a fast-paced and dynamic environment.

What To Expect (Job Responsibilities)

• Prepare and update 510(k) submissions and technical files, including legacy files from 2020.
• Conduct post-market surveillance activities including PMCF and PSUR and summarize findings.
• Translate design drawings into accessible documentation for non-technical audiences.
• Create and manage hyperlinked Word documents linked to internal and live documents.
• Collaborate with internal teams ensuring timely and accurate documentation following QMS procedures.

What Is Required (Qualifications)

• Experience in medical device regulatory affairs or corporate quality.
• Strong familiarity with 510(k) processes and technical file structures.
• Proficiency in Microsoft Word, particularly in hyperlinking and document structuring.
• Ability to interpret and summarize scientific literature.
• Knowledge of QMS, PMCF, and PSUR requirements.

How To Stand Out (Preferred Qualifications)

• Experience with SRN number lookup and product stewardship.
• Pharmaceutical tech file experience with willingness to train in medical device standards.

Key skills/competency

• QA
• Documentation
• 510(k)
• Regulatory
• QMS
• PMCF
• PSUR
• Microsoft Word
• Technical Files
• Medical Device