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Medical Device Risk Management Jobs in California

Viltis

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Senior Regulatory Affairs Specialist - Medical Devices

Alameda, CA · On-site

$50 - $65/hr

Knowledge of medical device risk management principles. * Experience supporting product line extensions, manufacturing changes, and labeling updates. * Experience within diabetes care, diagnostics ...

Hologic

Quality Engineer 4 - Risk Management

San Diego, CA · On-site

$76K - $98K/yr

Strong knowledge of medical device and/or IVD risk management principles across the full product lifecycle. * Advanced understanding of applicable regulatory and quality system requirements ...

BEPC INC

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Medical Device Assembler

Irvine, CA · On-site

$17 - $19/hr

Medical Device Assembler Location: Irvine, CA 92614 Employment Type: W2 Contract | 6 Months with ... Support Quality Management System (QMS), Environmental Management System (EMS), and applicable ...

BEPC INC

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Medical Device Assembler

Temecula, CA · On-site

$19.25 - $23.33/hr

Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in ...

BEPC INC

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Medical Device Assembler

Temecula, CA · On-site

$19.25 - $23.33/hr

Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in ...

BEPC INC

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Medical Device Assembler

Temecula, CA · On-site

$19.25 - $23.33/hr

Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in ...

BEPC INC

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Medical Device Assembler

Temecula, CA · On-site

$19.25 - $23.33/hr

Medical Device Assembler Location: Temecula, CA Employment Type: Full-Time / Contract Pay Rate: $19 ... management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in California

Medical Device Risk Management information

See California salary details

$50.8K

$110.1K

$167.8K

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

As of Sep 9, 2026, the average yearly pay for medical device risk management in California is $110,095.00, according to ZipRecruiter salary data. Most workers in this role earn between $88,800.00 and $127,300.00 per year, depending on experience, location, and employer.

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 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 job categories do people searching Medical Device Risk Management jobs in California look for?

The top searched job categories for Medical Device Risk Management jobs in California are:

What cities in California are hiring for Medical Device Risk Management jobs?

Cities in California with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in California as of September 2026, with employment types broken down into 1% As Needed, 62% Full Time, 32% Part Time, and 5% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $110,095 per year, or $52.9 per hour.

Senior Regulatory Affairs Specialist - Medical Devices

Alameda, CA • On-site

Viltis
See more jobs at Viltisexternal

$50 - $65/hr

Contractor

Retirement

Re-posted 8 hours ago

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Job description

Senior Regulatory Affairs Specialist – Medical Devices


Location: Alameda, CA
Schedule: Full-Time, 40 Hours/Week
Employment Type: Contract
Industry: Medical Devices / Diabetes Care


Position Overview


Viltis is seeking an experienced Senior Regulatory Affairs Specialist to support a leading medical device organization in San Diego, CA.


The ideal candidate will bring at least 7 years of Medical Device Regulatory Affairs experience, with particular expertise in regulatory change assessments and U.S. medical device submissions.

This individual will serve as a regulatory subject matter expert and partner closely with cross-functional teams to support new product approvals, maintain regulatory compliance for marketed products, and evaluate product, manufacturing, labeling, and technical changes for regulatory impact.


Key Responsibilities

  • Perform and document regulatory change assessments for medical devices, manufacturing processes, product modifications, labeling changes, and other technical changes.
  • Support the preparation, review, and management of U.S. medical device regulatory submissions.
  • Help ensure timely regulatory approval of new medical devices and continued compliance and approval of marketed products.
  • Serve as the Regulatory Affairs representative on cross-functional project teams.
  • Provide regulatory guidance to product development, manufacturing, quality, engineering, and marketing teams.
  • Assess manufacturing changes, product line extensions, technical documentation, and labeling for regulatory impact.
  • Interpret applicable medical device regulations, guidance documents, and regulatory requirements.
  • Participate in the development and implementation of regulatory strategies for new and existing products.
  • Support product planning and lifecycle management activities from a regulatory perspective.
  • Participate in risk management activities and ensure regulatory considerations are appropriately incorporated into project decisions.
  • Monitor regulatory policy, intelligence, and emerging requirements that may impact products or business activities.
  • Participate in continuous improvement initiatives related to regulatory processes and documentation.
  • Maintain clear, accurate, and audit-ready regulatory documentation.


Required Qualifications

  • 7+ years of Medical Device Regulatory Affairs experience required.
  • Significant hands-on experience conducting regulatory change assessments.
  • Strong working knowledge of U.S. medical device regulatory requirements and submissions.
  • Experience supporting commercially marketed medical devices and product lifecycle activities.
  • Demonstrated ability to interpret regulatory requirements and determine their impact on product, manufacturing, labeling, and technical changes.
  • Experience working effectively with cross-functional teams including Quality, Engineering, Manufacturing, R&D, and Marketing.
  • Strong written and verbal communication skills.
  • Strong organizational skills with the ability to manage multiple regulatory priorities and deadlines.

Preferred Experience

  • Experience developing or contributing to medical device regulatory strategy.
  • Experience supporting regulatory submissions and maintaining market authorization for existing products.
  • Knowledge of medical device risk management principles.
  • Experience supporting product line extensions, manufacturing changes, and labeling updates.
  • Experience within diabetes care, diagnostics, combination products, or other highly regulated medical device environments is a plus.


About Viltis


Viltis partners with leading pharmaceutical, biotechnology, medical device, and life sciences organizations to provide specialized consulting and workforce solutions across Regulatory Affairs, Quality, Clinical, Engineering, and Scientific functions.


If you are an experienced Medical Device Regulatory Affairs professional with a strong background in regulatory change assessments and U.S. submissions, we encourage you to apply.