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Medical Device Labeling Jobs in Florida (NOW HIRING)

ARKRAY GROUP

Regulatory Affairs Associate

Doral, FL · On-site

... labeling program coordination, UDI/GUDID activities, facility registrations/device listings, import ... Florida Medical Technologist license and applicable certification (ASCP/AMT as outlined in

TSE Industries Inc

WHK Rubber Molding Operator

Clearwater, FL

$14.25 - $17.25/hr

... medical device components. Our state-of-the-art manufacturing facility operates in a clean, air ... Trim, package, label, and prepare finished products for shipment or next operations. * Maintain a ...

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Medical Device Labeling information

What is a medical device labeling?

A Medical Device Labeling job involves creating, reviewing, and managing labeling content for medical devices to ensure compliance with regulatory requirements. This includes instructions for use, packaging labels, and safety information for healthcare professionals and patients. Professionals in this role collaborate with regulatory, quality, and engineering teams to meet industry standards and country-specific regulations. Their work ensures that medical devices are used safely and effectively, reducing risks associated with improper usage.

What does a medical device labeling do?

Professionals in Medical Device Labeling are responsible for creating, reviewing, and updating product labels, instructions for use, and packaging materials to ensure compliance with regulatory standards. They often collaborate closely with regulatory affairs, engineering, and quality assurance teams to gather technical product information and incorporate feedback. Daily activities may also include managing document control processes, implementing labeling changes driven by new regulations or product updates, and preparing submissions for global markets. Attention to detail and the ability to manage multiple projects simultaneously are crucial for success in this role.

What are the key skills and qualifications needed to thrive in medical device labeling?

To thrive in Medical Device Labeling, you need a strong understanding of regulatory requirements (such as FDA and EU MDR), attention to detail, and experience with technical writing or documentation, often supported by a degree in life sciences or a related field. Familiarity with labeling management systems, document control tools, and knowledge of ISO standards are key technical qualifications, and certifications like RAC can be advantageous. Strong communication, collaboration, and organizational skills set candidates apart, as these roles often involve coordinating with cross-functional teams such as regulatory, engineering, and quality assurance. These capabilities ensure labeling materials meet strict compliance standards, avoid costly errors or recalls, and support timely product launch and patient safety.

What are popular job titles related to Medical Device Labeling jobs in Florida?

For Medical Device Labeling jobs in Florida, the most frequently searched job titles are:

What job categories do people searching Medical Device Labeling jobs in Florida look for?

The top searched job categories for Medical Device Labeling jobs in Florida are:

Medical Device Labeling jobs near you
Infographic showing various Medical Device Labeling job openings in Florida as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

Regulatory Affairs Associate

Doral, FL • On-site

ARKRAY GROUP
See more jobs at ARKRAY GROUPexternal

Full-time

Re-posted 29 days ago

Job description

Overview


Position Type: Full Time
Education Level: 4 Year Degree
Category: Health Care / Regulatory & Clinical Support

Job Description

Position Title: Junior or Assistant, Sales Support Division, Regulatory Team
 

Summary

Ability and knowledge to conduct the work listed in at least one of the major job duty areas (excluding General Duties), supporting ARKRAY’s compliance with applicable laws and regulations.

Essential Responsibilities

  • Provide hands-on support for on-site clinical studies, including training clinical site staff, monitoring and data verification, troubleshooting instrument issues, and preparing study materials (reagents/equipment).

  • Travel to clinical study sites for setup, training, monitoring, and other study support as needed.

  • Perform in-house evaluative/bench studies of ARKRAY products, new products, and competitive products for institutional knowledge and/or to support regulatory approval.

  • Ensure scientific work, data generation, and project activities comply with applicable requirements and standards; recommend and apply appropriate scientific approaches for product updates and future work.

  • Review and assess complaint investigation results related to Blood Glucose Monitoring Systems.

  • Act as Principal Investigator for ARKRAY in-house clinical studies as assigned, including maintaining required documentation and certifications for IRB review if needed.

  • Perform digital urine sediment analysis using image-based microscopy systems; review, classify, and verify cells, casts, crystals, and microorganisms.

  • Adhere to Quality Control policies, including documentation of QC activities, calibrations, maintenance, and performance monitoring.

  • Support Sales and Marketing by helping address FDA compliance-related questions or concerns from customers.

  • Support evaluation/validation of digital or image-based diagnostic systems; provide feedback on image classification performance, discrepancies, and limitations to support data integrity.

  • Participate in pre-/post-market regulatory activities as assigned (labeling review/approval, FDA submission support, consultant coordination, and 510(k) support with R&D).

  • Support product launch regulatory work such as Regulatory Master Plans, labeling program coordination, UDI/GUDID activities, facility registrations/device listings, import inspections/holds, and related documentation support.

  • Support quality system activities as assigned, including audit support, validation/change control support, supplier activities, internal audit participation, and QMS compliance activities (FDA QMSR, ISO 13485, OSHA).

  • Support complaint handling and post-market activities as assigned (risk reviews, recalls/field actions support, complaint meeting support, MDR support, vendor reporting, and daily call data review as applicable).

  • General duties may include coordinating office activities and processing company mail for the Miami facility as needed.

  • Perform other reasonably related duties as assigned by management.

Qualifications

  • Bachelor’s degree in Biology, Biochemistry, Chemistry, or related discipline.

  • 3–5 years of experience in a medical laboratory and/or medical device industry, with urinalysis IVD instruments for laboratory and manual microscopy experience (hematology/POC/consumer use preferred).

  • Clinical study management experience preferred.

  • Proficiency in Microsoft Office (Word, Adobe, Excel, PowerPoint).

  • Ability to travel domestically and internationally.

  • Urinalysis product use and manual microscopy experience.

  • Preferred/if required: Florida Medical Technologist license and applicable certification (ASCP/AMT as outlined in job description).

Physical Requirements

Heavy keyboarding / PC use

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities.

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