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Remote Medical Device Auditor Jobs in Virginia (NOW HIRING)

QCi

Remote Division: Technology Department: Engineering About Us Quantum Computing Inc. (QCi) (Nasdaq ... auditing device keys and access credentials. * Implement network configuration interfaces that ...

VB Spine

Sr. Regulatory Affairs Specialist

Leesburg, VA · On-site +1

$100K - $105K/yr

Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required) Company: VB Spine Looking for a career ... Working knowledge of US and EU medical device regulations (international experience a plus)

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Remote Medical Device Auditor information

What is a remote medical device auditor?

Remote Medical Device Auditors are professionals who evaluate medical device manufacturers' compliance with regulatory standards and quality systems, such as ISO 13485, without being physically present at the site. They conduct audits using digital tools, video conferencing, and document reviews to ensure products meet safety and quality requirements. This role requires strong knowledge of medical device regulations and excellent communication skills to work effectively with clients and regulatory bodies from a distance.

What skills and qualifications are needed to thrive as a remote medical device auditor?

To thrive as a Remote Medical Device Auditor, you need a solid understanding of medical device regulations (such as ISO 13485, FDA 21 CFR Part 820), quality management systems, and relevant industry experience, often supported by a degree in science, engineering, or a related field. Familiarity with auditing software, remote communication tools, and recognized auditor certifications (like IRCA or ASQ) is typically required. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for evaluating compliance and collaborating with client teams remotely. These competencies ensure thorough, accurate audits and help organizations maintain regulatory compliance and uphold product safety standards.

What are common challenges faced by remote medical device auditors, and how can they be managed?

Remote Medical Device Auditors often face challenges such as ensuring thorough compliance assessments without on-site access and effectively communicating with diverse client teams across different time zones. To manage these challenges, auditors leverage robust virtual collaboration tools, detailed documentation, and clear communication protocols. Staying up to date with evolving regulatory standards and maintaining strong organizational skills are also critical for success in this role. Proactive planning and flexibility help auditors adapt to varied client needs and maintain audit quality remotely.

What are the most commonly searched types of Medical Device Auditor jobs in Virginia?

The most popular types of Medical Device Auditor jobs in Virginia are:

What are popular job titles related to Remote Medical Device Auditor jobs in Virginia?

For Remote Medical Device Auditor jobs in Virginia, the most frequently searched job titles are:

What job categories do people searching Remote Medical Device Auditor jobs in Virginia look for?

The top searched job categories for Remote Medical Device Auditor jobs in Virginia are:

What cities in Virginia are hiring for Remote Medical Device Auditor jobs?

Cities in Virginia with the most Remote Medical Device Auditor job openings:

Remote Medical Device Auditor jobs near you

Medical Device Workflow & Validation Lead (Remote, Continental United States)

International Consulting Associates, Inc.

Arlington, VA • On-site, Remote

$130K - $160K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 5 days ago

Job description

About ICA, Inc.
ICA, Inc. is a rapidly growing company, located in the D.C./Metro area. We were founded in 2009 to assist government clients with evaluating and achieving their objectives. We have become a trusted advisor helping our clients by offering cutting-edge innovation and solutions to complex projects. Our small company has grown significantly, and we're overjoyed at the opportunity to expand yet again!
We are results-focused and have a proven track record supporting federal agencies and large government services primes in three main areas: Research and Data Analysis, Advanced-Data Science, and Strategic Services. We currently support multiple analytics and research programs across HHS.
At ICA, we believe our success starts with our people. We foster a collaborative "one team" environment where work-life balance isn't just talked about - it's prioritized. We're building dynamic, highly skilled teams in a welcoming and supportive atmosphere. If you're passionate about using your technical expertise to make a difference, we want to talk to you.
We are looking for a Medical Device Workflow & Validation Leadto join our growing team!
ABOUT THE ROLE:
We are hiring a Medical Device Workflow & Validation Lead that helps to represent the reviewer's perspective across our document intelligence platform, including product development and client delivery. You will help us understand how reviewers work, translate their needs into clear requirements, validate features from a domain perspective, and lead client demonstrations and user acceptance. This role is responsible for ensuring that alerts, evidence, and workflows provide genuine value without creating unnecessary reviewer burden or presenting automated findings as regulatory conclusions
KEY RESPONSIBILITIES:
  • Build strong working relationships with client reviewers and establish a regular, structured feedback process.
  • Lead discovery and validation sessions using prototypes and working software.
  • Translate reviewer needs into workflows, business rules, user stories, and measurable acceptance criteria.
  • Validate proposed requirements and workflows before development begins.
  • Partner with the Senior Product Manager to ensure requirements are accurate from a medical-device review perspective.
  • Define meaningful alert categories, priorities, reviewer actions, and escalation paths.
  • Evaluate alert relevance, false positives, false negatives, evidence quality, usability, and reviewer effort.
  • Test completed capabilities from a reviewer's perspective and identify missing requirements, confusing behavior, unsupported conclusions, and workflow gaps.
  • Lead client demonstrations, user acceptance testing, feedback capture, and acceptance or signoff.
  • Maintain traceability from the original client's needs through requirements, validation, and approval.
  • Improve domain understanding across product, engineering, data science, and leadership teams.

REQUIRED QUALIFICATIONS:
  • Previous experience as a medical-device reviewer with experience in medical-device regulatory review, regulatory affairs, quality assurance, clinical review, or related regulated-document field.
  • Strong understanding of medical-device submission documentation and review processes.
  • Experience gathering requirements and working directly with clients, reviewers, or other domain stakeholders.
  • Ability to translate complex domain needs into clear, testable product requirements.
  • Experience conducting user acceptance testing or structured software validation.
  • Ability to identify missing evidence, unsupported conclusions, workflow gaps, and unintended consequences.
  • Strong analytical, facilitation, documentation, and communication skills.
  • Credibility and confidence when working with client domain experts.
  • Comfort collaborating with product managers, engineers, data scientists, and UX teams.
  • Must be authorized to work in the United States and have lived in the US for 3 or more consecutive years.
  • Must be able and willing to obtain a Public Trust Clearance

USE OF AI ASSITIVE TECHNOLOGY
All application materials must be your own original work, and interviews must be completed independently. Use of AI-generated content in applications or AI assistance during interviews will result in disqualification.
BENEFITS:
We invest in our team members so you can live your best life professionally and personally, offering a competitive salary and benefits.
  • Health Insurance -100% employer-paid premiums - ICA covers the full cost of one of three offered medical plans
  • Dental Insurance
  • Vision insurance
  • Health Spending Account
  • Flexible Spending Account
  • Life and Disability insurance
  • 401(k) plan with company match
  • Paid Time Off (Vacation, Sick Leave and Holidays)
  • Education and Professional Development Assistance
  • Remote work from anywhere within the continental United States

LOCATION & TELEWORK
This is a remote position following Eastern Standard Time (EST). Candidates residing in the DMV area preferred.
ADDITIONAL INFORMATION:
ICA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity or expression, national origin, genetics, disability status, protected veteran status, age, or any other characteristic protected by state, federal or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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