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Medical Device Regulatory Jobs (NOW HIRING)

AstrixTechnology LLC

Be Seen First

Medical Device Assembler

Santa Rosa, CA · On-site

$20 - $25/hr

... regulatory advisory services and staffing solutions to the scientific community. We can assist in ... Medical device, Petrochemical and Clinical Research.

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Medical Device Regulatory information

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$18

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$62

How much do medical device regulatory jobs pay per hour?

As of Aug 10, 2026, the average hourly pay for medical device regulatory in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are some common challenges faced by professionals in medical device regulatory roles, and how can they be addressed?

Professionals in Medical Device Regulatory roles often face challenges such as keeping up with constantly evolving global regulations, coordinating with cross-functional teams, and ensuring timely submissions for product approvals. Navigating differing requirements across regions (e.g., FDA, EU MDR, TGA) can be complex and demands a proactive approach to regulatory intelligence. Building strong communication channels with R&D, quality, and clinical teams, as well as staying engaged with regulatory updates and training, can help manage these challenges effectively.

What is a medical device regulatory professional?

Medical Device Regulatory professionals are specialists who ensure that medical devices comply with the laws and regulations of the countries where they are marketed and sold. Their responsibilities include preparing and submitting documentation to regulatory authorities, monitoring changes in regulatory requirements, and collaborating with product development teams to ensure ongoing compliance. These professionals play a critical role in obtaining approvals or clearances for medical devices, enabling them to reach the market safely and efficiently. They also contribute to post-market surveillance and handle communication with regulators regarding product modifications or issues.

What is the difference between Medical Device Regulatory vs Medical Device Quality Assurance?

AspectMedical Device RegulatoryMedical Device Quality Assurance
CertificationsRegulatory Affairs Certification (RAC), ISO 13485 Lead AuditorISO 13485 Lead Auditor, CQE
Work EnvironmentRegulatory agencies, compliance departments, documentation reviewManufacturing sites, quality control labs, audit environments
Employer & Industry UsageMedical device companies, regulatory consulting firmsManufacturers, quality management organizations

Medical Device Regulatory professionals focus on ensuring products meet legal and regulatory requirements for market approval, while Medical Device Quality Assurance specialists concentrate on maintaining product quality through standards and audits. Both roles are essential in the medical device industry and often collaborate to ensure compliance and safety.

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

To thrive as a Medical Device Regulatory Specialist, you need a thorough understanding of medical device regulations, quality management systems, and often a degree in life sciences or engineering. Familiarity with regulatory submission systems (like FDA eSubmitter), ISO 13485, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, strong communication, and problem-solving skills help ensure compliance and effective collaboration with cross-functional teams. These capabilities are critical for navigating complex regulatory landscapes and ensuring safe, timely product approvals.
More about Medical Device Regulatory jobs
What cities are hiring for Medical Device Regulatory jobs? Cities with the most Medical Device Regulatory job openings:
What states have the most Medical Device Regulatory jobs? States with the most job openings for Medical Device Regulatory jobs include:
What job categories do people searching Medical Device Regulatory jobs look for? The top searched job categories for Medical Device Regulatory jobs are:
Medical Device Regulatory jobs near you
Infographic showing various Medical Device Regulatory job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Medical Device Quality Inspector

Stellar IT Group

Madison, WI • On-site

Full-time

Re-posted 6 days ago

Job description

Overview:
Medical Device Quality Inspector
Madison, WI (Onsite)
6+ Months
Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as ensuring the quality integrity of the product. Ensure work is completed in compliance with the company quality system and medical device regulations. Ensure work is completed in compliance with the company quality system and medical device regulations.
Essential Functions
• Performs one of three functions in the Quality department:
o Inspecting raw materials to meet production requirements
o Conducts in-process inspection of manufacturing product and processes
o Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits
• Assists in the Madison Manufacturing documentation control room.
• Completes documentation of activities performed, prepares and attaches material quality status labeling. Ensures storage and handling of product and labeling in a controlled and secure manner.
• Supports Quality through occasional conduct of investigations of nonconformance, assists with preventive actions associated with the QA unit.
• Performs quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.
Minimum Requirements
Education / Experience / Skills:
• High School diploma or equivalent
• One year's experience in a regulated work environment preferred
• Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing
Competencies:
• High Level of motivation; ability to work independently
• Detailed oriented
• Ability to work with computer-based systems daily
• Collaborator with strong levels of engagement with individuals and as a team member
• Good interpersonal skills; ability to communicate well, both verbally and written
Organizational Relationship/Scope:
Reports to the Quality Control Manager. This position is accountable for delivery of prompt investigative work and detailed reporting. Working across multiple functions, this position collaborates primarily with manufacturing, engineering and quality to assess nonconforming product and support supplier quality issues.
Working Conditions:
Manufacturing facility of medical devices and accessories. Controlled environmental working conditions.
Skills:
QUALITY,Medical Devices

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