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Medical Device Risk Management Jobs in Boca Raton, FL

Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre ... US FDA Manage commercial device tracking Develop clinical protocols and clinical study reports ...

Investigate account activity that exceeds risk management system parameters and make real-time ... Medical, dental, vision, life, and disability insurance options available from day one.

Medical Orthopedic Rep

Hollywood, FL · On-site

$91K - $122K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Ability to effectively manage a physician-based customer base * Skills to communicate clinically ...

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Medical Device Risk Management information

See Boca Raton, FL salary details

$48.9K

$105.9K

$161.3K

How much do medical device risk management jobs pay per year?

As of Jun 29, 2026, the average yearly pay for medical device risk management in Boca Raton, FL is $105,863.00, according to ZipRecruiter salary data. Most workers in this role earn between $85,400.00 and $122,400.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Medical Device Risk Management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a Medical Device Risk Management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.
What cities near Boca Raton, FL are hiring for Medical Device Risk Management jobs? Cities near Boca Raton, FL with the most Medical Device Risk Management job openings:

General Manager for Medical Devices and Hospital Supplies / Integrator

Medical Device Distribution Company

Miami Gardens, FL • On-site

$95K - $110K/yr

Full-time

Retirement, PTO

Posted 6 days ago

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Key responsibilities

  • Lead and manage the operations team across warehouse, purchasing/admin, compliance/quality, and technical operations.

  • Own and manage the company's operational KPIs and weekly scorecard.

  • Oversee supply chain, purchasing, inventory management, supplier performance, and ensure regulatory compliance.


Job description

The General Manager/Integrator is the central hub of the company — the person who turns strategy into execution. You will lead our operations team, manage KPIs, drive accountability, and ensure that our supply chain, warehouse, compliance, and administrative functions operate at a high standard.

This role reports directly to the Owner and is responsible for the performance of the entire operational organization.

Key Responsibilities

  • Lead and manage the operations team (warehouse, purchasing/admin, compliance/quality, technical operations)
  • Own the company’s operational KPIs and weekly scorecard
  • Ensure consistent execution of processes, SOPs, and standards
  • Oversee supply chain, purchasing, inventory management, and supplier performance
  • Maintain regulatory compliance (ISO 13485, NABP, forced‐labor compliance)
  • Oversee warehouse operations, fulfillment accuracy, and efficiency
  • Govern ERP usage (Bizowie) and ensure data integrity
  • Approve artwork, packaging, and product documentation
  • Drive continuous improvement and operational problem‐solving
  • Lead weekly meetings, set priorities, and hold the team accountable
  • Support the owner by removing bottlenecks and ensuring smooth daily operations

What We’re Looking For

  • 5+ years of operations leadership experience (distribution, medical device, manufacturing, or regulated industry preferred)
  • Strong process orientation — you believe in structure, consistency, and accountability
  • Experience managing people and driving performance
  • Comfortable making decisions, enforcing standards, and resolving conflict
  • Strong analytical skills and familiarity with KPIs and dashboards
  • ERP experience (any system; Bizowie is a plus)
  • Excellent communication and organizational skills
  • Ability to lead in a fast‐moving, growing environment
  • A stabilizer — someone who brings order, clarity, and predictability

Who Will Succeed in This Role

This role is ideal for someone who is:

  • Structured — you like systems, processes, and clarity
  • Decisive — you don’t hesitate to make a call
  • Accountability‐driven — you hold people to standards
  • Operationally minded — you enjoy execution more than ideation
  • Detail‐oriented — you care about accuracy and consistency
  • Calm under pressure — you bring stability to the team

This role is not a fit for someone who prefers creative work, flexible structure, or individual contributor tasks. This is a leadership role for someone who wants to run the operation.

Company Description

We are a well-established brand and private label supplier of quality veterinary products working with some of the industry’s largest distributors. We provide a healthy work environment, competitive salaries and attractive working hours; making our company an amazing place to work and grow.