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Medical Device Analyst Remote Jobs (NOW HIRING)

Medical Device QMS Auditor

Concord, NC ยท Remote

$98K - $123K/yr

Analyze and assess quality management systems with emphasis on design controls, manufacturing ... LI-REMOTE #LI-MS1 About Us BSI is a business improvement and standards company and for over a ...

Sales Representative Medical Device

Raleigh, NC ยท On-site +1

$90K - $100K/yr

... in a medical device industry preferred * 1+ years capital equipment sales experience preferred ... We recognize the benefits of flexible, remote working arrangements for eligible roles and are ...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... The Complaint Analyst Manager is responsible for planning, assigning, and leading the team ...

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Contract Analyst

Moundsview, MN ยท Remote

$40 - $45/hr

Contract Analyst Client: Med Device Manufacturing Industry Location: Remote Duration: 2 Years (Possible Extension) Shift: 1st Shift Job Overview: Seeking a Contract Analyst to support contract ...

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Medical Device Analyst Remote information

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$31K

$73.3K

$130K

How much do medical device analyst remote jobs pay per year?

As of Jul 21, 2026, the average yearly pay for medical device analyst remote in the United States is $73,261.00, according to ZipRecruiter salary data. Most workers in this role earn between $52,500.00 and $87,000.00 per year, depending on experience, location, and employer.

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

AspectMedical Device Analyst RemoteMedical Device Quality Assurance Specialist
Required CredentialsBachelor's in life sciences or engineering, certifications like RAC or ISO auditorBachelor's in quality assurance, certifications like CQE or ISO auditor
Work EnvironmentRemote, primarily data analysis and reportingOn-site or hybrid, focusing on audits and process validation
Employer & Industry UsageMedical device companies, regulatory agencies, consulting firmsManufacturers, regulatory bodies, healthcare companies
Search & Comparison IntentUnderstanding remote roles in medical device analysisComparing quality assurance roles in medical devices

The Medical Device Analyst Remote role focuses on analyzing data, regulatory compliance, and reporting remotely, while the Medical Device Quality Assurance Specialist emphasizes on-site quality audits, process validation, and compliance checks. Both roles require similar certifications and industry knowledge but differ mainly in work environment and specific responsibilities.

What are the typical collaboration and communication expectations for a remote Medical Device Analyst?

As a remote Medical Device Analyst, you'll frequently collaborate with cross-functional teams, including regulatory affairs, quality assurance, and engineering, often through virtual meetings and project management tools. Clear and proactive communication is essential to keep projects on track and ensure compliance with medical device regulations. You can expect regular check-ins, documentation sharing, and status updates to maintain alignment across distributed teams. Building strong virtual relationships and being comfortable with digital collaboration platforms are key to success in this role.

What are the key skills and qualifications needed to thrive as a Medical Device Analyst (Remote), and why are they important?

To thrive as a Medical Device Analyst (Remote), you need a background in biomedical engineering, life sciences, or a related discipline, along with strong analytical and research abilities. Familiarity with regulatory databases, medical device reporting systems, and data analysis tools like Excel or SAS is typically required. Attention to detail, effective communication, and self-motivation are crucial soft skills for remote collaboration and accurate analysis. These competencies ensure precise evaluation of device safety and compliance while enabling efficient teamwork in a virtual environment.

What does a Medical Device Analyst do when working remotely?

A Medical Device Analyst working remotely is responsible for evaluating, monitoring, and reporting on the performance and compliance of medical devices. They analyze data from clinical trials, adverse event reports, and post-market surveillance to ensure devices meet regulatory standards and safety requirements. Remote analysts often collaborate with cross-functional teams via digital platforms, prepare detailed reports, and may assist with quality assurance or regulatory submissions without needing to be on-site.
More about Medical Device Analyst Remote jobs
What cities are hiring for Medical Device Analyst Remote jobs? Cities with the most Medical Device Analyst Remote job openings:
What are the most commonly searched types of Medical Device Analyst jobs? The most popular types of Medical Device Analyst jobs are:
What states have the most Medical Device Analyst Remote jobs? States with the most job openings for Medical Device Analyst Remote jobs include:
What job categories do people searching Medical Device Analyst Remote jobs look for? The top searched job categories for Medical Device Analyst Remote jobs are:
Infographic showing various Medical Device Analyst Remote job openings in the United States as of July 2026, with employment types broken down into 71% Full Time, 6% Part Time, 6% Temporary, and 17% Contract. Highlights an 100% Remote job distribution, with an average salary of $73,261 per year, or $35.2 per hour.

Medical Device QMS Auditor

BSI Group

Concord, NC โ€ข Remote

$98K - $123K/yr

Full-time

Medical, Dental, Life, Retirement, PTO

Re-posted 12 days ago


Job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Job Title: Medical Device QMS Auditor

Location: Candidates must reside in one of the following states: IL, MN, WI, IN, NJ, MA, PA, OH.

BSI (British Standards Institution) is the global business standards company that equips businesses with the solutions to turn standards of best practice into habits of excellence.

Our Medical Devices (or Regulatory Services) team ensures patient safety while supporting timely market access for our clients' medical device products globally. BSI is an accredited ISO 13485 Certification Body recognized in many global markets.

This is a travel based position with extensive travel to medical device manufacutering sites. Candidate must be comfortable with overnight travel of 13-15 days out of every month.

Essential Responsibilities

  • Analyze and assess quality management systems with emphasis on design controls, manufacturing controls, production processes, process validation, verification/validation, and testing activities, ensuring compliance with ISO 13485, CE Marking, and MDSAP schemes.
  • Assess manufacturing processes including production controls, process validation, risk management, supplier controls, and design transfer activities.
  • Prepare assessment reports and communicate findings to clients, providing clear direction for corrective actions where appropriate.
  • Recommend the issue, re-issue, or withdrawal of certificates in accordance with BSI policies and procedures.
  • Lead assessment teams, ensuring quality of service and effective working relationships with clients and team members.

Education & Technical Qualifications

  • Technical degree (Bachelor's, or higher) in Engineering, Science, or a related technical discipline required. Relevant fields include Biomedical, Mechanical, Electrical, or Chemical Engineering; Materials Science; Biology; Microbiology; Chemistry; or related technical fields applicable to medical devices, SaMDs, or IVDs.
  • Minimum of 4 years' experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating devices. Candidates must have personally worked with devices, specifications, or code, indicate the types and classifications of devices, and demonstrate their level of involvement on their CV. Regulatory or audit experience only is insufficient.
  • Detailed hands-on experience with design and manufacturing/production controls, including process validation (IQ/OQ/PQ), risk management, supplier controls, CAPA, nonconforming product management, and change control.
  • Knowledge of regulatory requirements and quality management standards including ISO 13485, MDSAP, FDA QSR (21 CFR 820), and EU MDR/IVDR are a plus

Core Competencies

  • Strong verbal and written communication skills, and attention to detail.
  • Ability to work under pressure and meet deadlines.
  • Self-motivated, flexible, and excellent time management/planning skills.
  • Willingness to travel extensively.
  • Enthusiastic, committed team player.
  • Business development and public speaking skills are considered advantageous.

Preferred Qualifications

  • Experience with process validation, equipment qualification, and manufacturing process development.
  • Experience in design and development activities, including design controls and design transfer.
  • Hands-on experience with software-controlled medical devices, SaMD, or automated manufacturing systems.
  • Experience auditing or assessing quality management systems compliant with ISO 13485, CE Marking, and MDSAP.
  • Experience with risk management (ISO 14971), sterile medical devices, aseptic processing, or cleanroom manufacturing.
  • Experience leading hands-on teams in manufacturing, testing, or validation.
  • Lead Auditor certification (ISO 13485, MDSAP, or equivalent) preferred.
  • Previous experience working for a Notified Body, Regulatory Body, or Certification Body preferred.
  • Advanced degree (MS, PhD) in engineering, science, or related technical discipline preferred.

The salary for this position can range from $98,100 to $123,860 annually; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons. BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.

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About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.
Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society's critical issues - from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.