Talentify
REMOTE QA Documentation Specialist, Medical Device
NewJob Description
- Req#: JP-005601981
Employer Industry: Medical Device Regulatory Affairs
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
- 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 into abstracts
- 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 to ensure timely and accurate documentation following established 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, especially 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
- Candidates with pharmaceutical tech file experience may be considered if willing to train into medical device standards
#MedicalDevices #RegulatoryAffairs #QualityAssurance #RemoteWork #CareerOpportunity
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