Talentify
REMOTE Quality Assurance Documentation Specialist
This job is now closed
Job Description
- Req#: JP-005600745
Employer Industry: Medical Device Regulatory Affairs
Why Consider this Job Opportunity:
- Salary up to $40.00/hr
- Comprehensive medical, dental, and vision benefits
- 401(k) retirement plan with pre-tax and Roth post-tax contributions available
- Fully remote position, providing flexibility in work location
- Opportunity for training in quality management systems and regulatory documentation
- Supportive team environment in a fast-paced and dynamic work setting
What to Expect (Job Responsibilities):
- Prepare and update 510(k) submissions and technical files, including legacy files
- 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 linking to internal and live documents
- Collaborate with internal teams to ensure timely and accurate documentation
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
#MedicalDevice #RegulatoryAffairs #QualityAssurance #RemoteWork #CareerOpportunity
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