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Medical Device Consultant information

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$31K

$148.2K

$399K

How much do medical device consultant jobs pay per year?

As of Jul 25, 2026, the average yearly pay for medical device consultant in the United States is $148,159.00, according to ZipRecruiter salary data. Most workers in this role earn between $97,500.00 and $181,500.00 per year, depending on experience, location, and employer.

How does a Medical Device Consultant typically collaborate with regulatory and clinical teams during product development?

A Medical Device Consultant often works closely with regulatory affairs and clinical teams to ensure that new devices meet all compliance and safety standards throughout the development process. This involves coordinating the preparation of documentation for regulatory submissions, advising on clinical trial design, and helping interpret regulatory guidelines. Effective collaboration ensures that the product not only meets legal requirements but is also positioned for smooth market entry. Consultants act as liaisons, translating complex regulatory language and clinical needs into actionable steps for the product team.

What is the difference between Medical Device Consultant vs Medical Device Sales Representative?

AspectMedical Device ConsultantMedical Device Sales Representative
CredentialsRelevant certifications, industry knowledgeSales training, product knowledge
Work EnvironmentConsulting firms, healthcare facilitiesMedical device companies, hospitals
Employer & Industry UsageHealthcare consulting firms, manufacturersMedical device companies, distributors
Search & Comparison IntentUnderstanding consulting roles, industry expertiseSales strategies, product promotion

Medical Device Consultants focus on advising healthcare providers on device selection, compliance, and implementation, leveraging industry expertise. In contrast, Medical Device Sales Representatives primarily promote and sell devices to hospitals and clinics. While both roles require industry knowledge, consultants emphasize consulting and compliance, whereas sales reps focus on sales and client relationships.

What does a Medical Device Consultant do?

A Medical Device Consultant provides expert advice to companies and healthcare providers regarding the development, regulation, marketing, and implementation of medical devices. They help ensure products comply with relevant health and safety regulations, assist in navigating clinical trials, and advise on market entry strategies. Consultants often collaborate with research and development teams, regulatory agencies, and sales departments to optimize device design and commercialization. Their expertise can be invaluable for startups, established manufacturers, and hospitals seeking to adopt new technologies.

What are the key skills and qualifications needed to thrive as a Medical Device Consultant, and why are they important?

To thrive as a Medical Device Consultant, you need a strong background in life sciences or engineering, in-depth knowledge of medical device regulations, and relevant industry experience. Familiarity with regulatory compliance systems such as FDA 510(k), ISO 13485, and clinical trial management tools is typically required. Outstanding communication, problem-solving, and relationship-building skills help consultants effectively guide clients and navigate complex projects. These skills are critical to ensuring regulatory success, client satisfaction, and the safe introduction of new medical devices to the market.
More about Medical Device Consultant jobs
What cities are hiring for Medical Device Consultant jobs? Cities with the most Medical Device Consultant job openings:
What states have the most Medical Device Consultant jobs? States with the most job openings for Medical Device Consultant jobs include:
What job categories do people searching Medical Device Consultant jobs look for? The top searched job categories for Medical Device Consultant jobs are:
Medical Device Consultant jobs near you
Infographic showing various Medical Device Consultant job openings in the United States as of July 2026, with employment types broken down into 1% Locum Tenens, 88% Full Time, 7% Part Time, and 4% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $148,159 per year, or $71.2 per hour.
CardioMed Device Consultants- Principal Consultant

CardioMed Device Consultants- Principal Consultant

BDC Laboratories

Edgewater, MD • Remote

Full-time

Posted 9 days ago

Job description

About CardioMed:

CardioMed Device Consultants is expanding and seeking an experienced Principal Consultant to serve as a strategic partner to companies developing novel Class II and Class III implantable and interventional medical devices, including digital health technologies.

This role is ideal for a senior regulatory professional with deep FDA experience who enjoys working closely with innovative medical device companies as a trusted regulatory advisor, while also contributing to client development and growth of long-term partnerships.

The Principal Consultant supports U.S. regulatory programs across the full product lifecycle-including early development, clinical investigations, marketing applications, and post-market activities-and collaborates with sponsor leadership to shape regulatory strategy, support FDA interactions, and expand client relationships.

CardioMed Device Consultants is a specialized medical device regulatory consulting firm known for:

  • Technical rigor in preclinical testing and regulatory strategy
  • Thoughtful, effective FDA interactions
  • Long-term partnerships with medical device innovators

Our team includes former FDA reviewers, engineers, clinicians, scientists, and regulatory strategists with extensive experience supporting Class II and Class III medical devices, including Pre-Submissions, IDEs, 510(k)s, PMAs, HDEs, and post-market programs.

Role Overview

As a Principal Consultant, you will provide strategic regulatory guidance and preclinical testing support to medical device manufacturers, working directly with sponsor leadership and cross-functional teams. You will play a key role in shaping regulatory pathways, preclinical testing strategies, contributing to FDA submissions, and supporting FDA interactions for complex and novel technologies.

Key Qualifications

  • Professional Experience: Strongly preferred 4–5 years of experience at the U.S. Food and Drug Administration (FDA) or equivalent senior-level experience in medical device regulatory affairs.
  • Strategic Leadership: Demonstrated ability to lead Q-Submissions and support FDA review of complex preclinical safety programs and clinical trial designs.
  • Subject Matter Expertise: Demonstrated technical expertise in Class II and Class III medical device standards, with subject matter expertise in at least one preclinical testing area (e.g., biocompatibility, in vivo studies, software verification and validation etc.). Familiarity with Software as a Medical Device (SaMD), including cybersecurity and AI/ML considerations, is a plus.
  • Analytical Writing: Strong technical writing skills, with the ability to translate complex clinical and preclinical data into clear, persuasive regulatory narratives for IDEs and marketing applications.
  • Quality Systems Knowledge: Working knowledge of 21 CFR Part 820 (Quality System Regulation) and ISO 13485, with the ability to align design controls with regulatory submissions.
  • Communication: Demonstrated ability to clearly communicate complex regulatory issues and risk to senior and executive stakeholders.
  • Global Awareness: Broad understanding of global regulatory environments-particularly EU and Japan-to support client global launch strategies beyond the U.S. market.

Key Responsibilities

  • Strategic Planning: Develop comprehensive regulatory strategies to support the development and market entry of novel Class II and Class III implantable, interventional, and digital health devices.
  • FDA Submissions: Lead or substantially contribute to the preparation, authoring, and review of FDA regulatory submissions, including Pre-Submissions, IDEs, 510(k)s, PMAs, and De Novo applications.
  • Agency Interaction: Serve as a primary liaison with the FDA's Center for Devices and Radiological Health (CDRH); coordinate and participate in Pre-Submission meetings and other formal FDA interactions on behalf of CardioMed clients.
  • Lifecycle Management: Provide regulatory and preclinical testing guidance across the full product lifecycle, from early design considerations and feasibility assessments through post-market compliance and reporting.
  • Technical Writing & Review: Draft and critically review technical documents, white papers, manuscripts, and device labeling/Instructions for Use (IFU) to ensure scientific accuracy and regulatory compliance.
  • Compliance Interpretation: Interpret complex medical device regulations and evolving FDA guidance to identify efficient and appropriate regulatory pathways for emerging and breakthrough technologies.
  • Regulatory Intelligence: Monitor and advise on changes in U.S. and global regulatory landscapes relevant to CardioMed clients.
  • Client Collaboration: Conduct regulatory due diligence and collaborate with cross-functional teams to integrate regulatory requirements into early-stage product development for startup, mid-size, and large medical device manufacturers.
  • Business Development: Contribute to business development efforts by supporting client engagements, identifying opportunities for expanded regulatory support, and helping build long-term client relationships.
  • Public Speaking: Represent CardioMed as a speaker or panelist at industry conferences such as Transcatheter Cardiovascular Therapeutics (TCT), EuroPCR, Cardiovascular Research Technologies (CRT), and other relevant medical device forums.
  • Educational Programming: Design and deliver customized regulatory and preclinical testing training workshops for medical device manufacturers, with emphasis on FDA submission strategy and evolving FDA guidance, ASTM, AAMI, and ISO standards.
  • Industry Engagement: Actively participate in professional societies (e.g., RAPS, AdvaMed) to remain current on policy developments and contribute to discussions on regulatory pathways for novel technologies.
  • Mentorship & Knowledge Sharing: Mentor junior consultants and translate regulatory feedback into shared lessons that strengthens the expertise of the CardioMed team

Job Posted by ApplicantPro