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Medical Device Regulatory Jobs (NOW HIRING)

Kellton Tech

Medical Device Technician

Madison, WI · On-site

$38K - $48K/yr

Ensure work is completed in compliance with company quality system and medical device regulations. Essential Functions * Assemble, test, and repair work per established work instructions, policies ...

Exactech

Regulatory Specialist

Familiarity with medical device registration and maintenance requirements in international markets. * Experience coordinating regulatory documentation and certificate management activities.

New

Advita Ortho

Regulatory Specialist

Familiarity with medical device registration and maintenance requirements in international markets. * Experience coordinating regulatory documentation and certificate management activities.

New

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Excel Medical Products

Medical Device Assembly

Wixom, MI · On-site

$16 - $17/hr

Document production activities, lot traceability, and quality records per FDA and ISO regulations ... Prior experience in medical device assembly, electronics assembly, or precision manufacturing ...

Experis

Regulatory Specialist Sr

Alameda, CA · On-site

$55 - $58/hr

What's Needed? * Minimum of 7 years of experience in Medical Device Regulatory Affairs. * Extensive knowledge of US Medical Device Submissions and regulatory change assessments. * Strong ...

Envista Holdings Corporation

WI · On-site

$120 - $180/hr

Develop and lead global regulatory strategies to secure and maintain approvals for Versah's medical device portfolio, with primary ownership of emerging markets.* Interpret global and regional ...

Abbott

Regulatory Specialist Sr

Alameda, CA · On-site

Must have 7 years of experiences in Medical Device Regulatory Affairs Key Skills & Responsibilities * Considered as highly experienced with regulatory change assessments. * Working knowledge in US ...

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Medical Device Regulatory information

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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 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Medical Device Technician

Kellton Tech

Madison, WI • On-site

$38K - $48K/yr

Contractor

Re-posted 28 days ago

Job description

Requisition Title:   Medical Device Technician
Location: Madison, WI (Onsite)
Scope of Work:
Assemble and test medical device assemblies, final products, and accessories per the manufacturing documentation provided. Perform assembly diagnosis, repair, and test equipment maintenance with supervision. Ensure work is completed in compliance with company quality system and medical device regulations.
Essential Functions
  • Assemble, test, and repair work per established work instructions, policies and procedures.
  • Performs assembly diagnosis and repair.
  • Responsible for successful completion of all training in a timely fashion. 
  • Maintain an organized and professional workspace.
  • Notifies area Supervisor and or Team Lead of quality concerns.
  • Capability to train other production assemblers as needed.
  • Operating within standard operating procedures (SOPs) and assembly drawings.
  • Communicate with quality and facilities any time there is an issue with the product or equipment. 
  • Provide guidance in problem diagnosis and resolution with team members.
  • Assist in development and revisions of Standard Operating Procedures (SOP), Work Instructions (WI) device history records, or other quality documentation, as necessary, to support production processes.
  • Strong attention to detail, while multi-tasking under strict deadlines.
  • Comply with EHS and Quality procedures, regulations and policies.
  • Ability to work scheduled or expanded shifts, holidays and/or off-shift duties, as necessary.
  • Other duties as assigned. 

Minimum Requirements

Education / Experience / Skills:
 
  • Bachelor’s degree in engineering or related scientific field. Associate’s degree with 2+ years’ experience or High School Diploma with 6+ years of experience in similar position.
  • Ability to work independently and motivate staff to meet required deadlines.
  • Problem solving and process improvement skills.

Desired Qualifications:
 
  • Experience working in cGMP setting and controlled documentation
  • SAP skills and experience.
  • Six Sigma belt or LEAN ideology.