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Remote Complaint Handling Medical Device Jobs in Reston, VA

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)

ConvaTec

Clinical Strategy Lead

Washington, DC · On-site +1

Experience in a medical device, pharmaceutical, or academic setting is a plus. Besides your ... Remote Beware of scams online or from individuals claiming to represent Convatec A formal ...

IQVIA

Manager, RHEMA

Washington, DC · Remote

$95K - $239K/yr

... medical device and diagnostics industry. Together, we support innovation from concept to ... Work Environment Professional office or remote work environment with occasional travel for client ...

IQVIA

Manager, RHEMA

Washington, DC · Remote

$95K - $239K/yr

... medical device and diagnostics industry. Together, we support innovation from concept to ... Work Environment Professional office or remote work environment with occasional travel for client ...

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All JobsComplaint Handling Medical Device JobsRemote Complaint Handling Medical Device JobsRemote Complaint Handling Medical Device Jobs in Reston, VA

Remote Complaint Handling Medical Device information

What is a remote complaint handling medical device specialist?

Remote complaint handling roles in the medical device industry involve managing product issues, customer feedback, and adverse event reports from a remote location rather than onsite. Professionals in these positions are responsible for receiving, documenting, and investigating complaints about medical devices to ensure patient safety and regulatory compliance. They also communicate with customers, coordinate with quality and regulatory teams, and help initiate corrective actions when needed. This role is crucial for maintaining product quality and meeting regulatory requirements, even when working from home or a remote office.

What are some common challenges faced by remote complaint handling medical device specialists, and how can they be overcome?

Remote complaint handling specialists in the medical device industry often face challenges such as coordinating across time zones, ensuring clear communication with both customers and internal teams, and maintaining compliance with strict regulatory requirements. To overcome these hurdles, it's important to develop strong organizational skills, leverage collaboration tools, and stay updated on industry regulations. Building effective communication channels and participating in regular team meetings can also help ensure that information is accurately captured and acted upon in a timely manner.

What are the key skills and qualifications needed to thrive as a remote complaint handling medical device specialist?

To excel as a Remote Complaint Handling Medical Device Specialist, you need a strong understanding of medical device regulations, complaint management processes, and typically a background in life sciences or biomedical engineering. Familiarity with complaint tracking software, quality management systems (QMS), and regulatory databases such as FDA's MAUDE is essential. Excellent written communication, problem-solving skills, and attention to detail help you effectively document and resolve complaints while collaborating with cross-functional teams. These competencies ensure compliance, patient safety, and timely resolution of product issues, which are critical for regulatory adherence and customer trust.

What is the difference between Remote Complaint Handling Medical Device vs Remote Medical Device Quality Assurance Specialist?

AspectRemote Complaint Handling Medical DeviceRemote Medical Device Quality Assurance Specialist
CertificationsISO 13485, FDA regulations, complaint handling trainingISO 13485, FDA regulations, audit and quality management certifications
Work EnvironmentCustomer service, complaint investigation, documentationQuality audits, process improvement, compliance documentation
Employer & Industry UsageMedical device manufacturers, post-market surveillanceMedical device companies, quality management teams

While both roles involve working within the medical device industry and require knowledge of ISO 13485 and FDA regulations, the Remote Complaint Handling Medical Device focuses on investigating and resolving customer complaints, whereas the Remote Medical Device Quality Assurance Specialist emphasizes maintaining quality standards and conducting audits. Understanding these differences helps professionals choose the right career path or job search focus.

What are popular job titles related to Remote Complaint Handling Medical Device jobs in Reston, VA? For Remote Complaint Handling Medical Device jobs in Reston, VA, the most frequently searched job titles are:
What job categories do people searching Remote Complaint Handling Medical Device jobs in Reston, VA look for? The top searched job categories for Remote Complaint Handling Medical Device jobs in Reston, VA are:
What cities near Reston, VA are hiring for Remote Complaint Handling Medical Device jobs? Cities near Reston, VA with the most Remote Complaint Handling Medical Device job openings:
Remote Complaint Handling Medical Device jobs near you

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

ICA.ai

Arlington, VA • Remote

$130K - $160K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 5 days ago

Job description

About ICA, Inc.

International Consulting Associates, 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 Lead to 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.