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Remote Medical Device Startup Jobs (NOW HIRING)

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

Job Title: Medical Device QMS Auditor Location: Candidates must reside in one of the following ... LI-REMOTE #LI-MS1 About Us BSI is a business improvement and standards company and for over a ...

Vitrolife Group

... Medical Device & Equipment Account Manager to join our North American Sales Team. This role is ... Department Sales Locations Dallas, Houston Remote status Fully Remote Employment type Full-time

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How much do remote medical device startup jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for remote medical device startup in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

What is a remote medical device startup?

A remote medical device startup is a company that designs, develops, or sells medical devices while operating primarily through remote or virtual teams. Instead of having a traditional office-based setup, employees work from different locations, often collaborating online. These startups leverage digital tools to innovate in healthcare technology, sometimes creating devices for telemedicine or remote patient monitoring. Working remotely can help the company access a wider talent pool and reduce overhead costs. Many remote medical device startups focus on agile development and rapid prototyping to bring new solutions to the healthcare market.

What are the key skills and qualifications needed to thrive at a remote medical device startup?

To thrive at a remote medical device startup, you need a strong background in biomedical engineering, product development, and regulatory compliance, often supported by relevant degrees or certifications. Familiarity with tools like CAD software, project management platforms, and FDA or ISO regulatory systems is typically required. Exceptional communication, self-motivation, and problem-solving skills are crucial for collaborating across remote teams and adapting to rapid changes. These skills and qualities ensure product innovation, regulatory success, and effective teamwork in a dynamic, distributed environment.

What are some common challenges faced by team members working remotely at a medical device startup?

Working remotely at a medical device startup often involves navigating time zone differences, maintaining clear communication across teams, and ensuring compliance with industry regulations without in-person oversight. Team members may find it challenging to collaborate on hands-on tasks, such as prototype development or device testing, which typically require coordination with local facilities or partners. However, startups usually foster a flexible, innovative environment that encourages proactive communication and creative problem-solving, making these challenges manageable for motivated professionals.
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Remote Medical Device Startup jobs near you
Infographic showing various Remote Medical Device Startup job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $103,662 per year, or $49.8 per hour.

Medical Device QMS Auditor

BSI Group

Concord, NC • Remote

$98K - $123K/yr

Full-time

Medical, Dental, Life, Retirement, PTO

Re-posted 15 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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#LI-MS1

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.

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