Medical Device Quality Assurance

Quality Assurance Documentation Specialist

We are seeking a detail-oriented and proactive Quality Regulatory Associate to support our regulatory and quality documentation efforts. This role is critical in compressing nine months of regulatory work into a 45-day window, focusing on 510(k) submissions and technical file updates in preparation for an upcoming inspection.

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 perform journal reviews to summarize findings into abstracts.
• Translate design drawings into accessible documentation for non-technical audiences.
• Create and manage hyperlinked Word documents, linking to internal and live documents.
• Assist with BioComp and cybersecurity tasks, and verify SRN numbers as needed.
• Follow established QMS procedures and collaborate with internal teams to ensure timely and accurate documentation.

Essential Skills

• 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.

Additional Skills & Qualifications

• Experience with SRN number lookup and product stewardship is a plus.
• Candidates with pharmaceutical tech file experience may be considered if willing to train into medical device standards.

Work Environment

The role offers comprehensive documentation and QMS training, along with work instruction guidance and onboarding. You will collaborate with a dedicated team in a fast-paced and dynamic work setting, utilizing technologies such as Microsoft Word and Excel to manage and structure technical files and regulatory documents.

Job Type & Location

This is a Contract position based out of Charlotte, North Carolina.

Pay and Benefits

The pay range for this position is $30.00 - $40.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 15, 2025.