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Medical Device Risk Management Jobs in Gainesville, GA

IFG Companies

Risk Management Actuary

Alpharetta, GA · On-site

$150K - $200K/yr

Draft POSITION SUMMARY The Risk Management Actuary ("RMA") plays a key role in supporting IFG ... IFG Companies offers competitive compensation and benefits, currently including medical, dental ...

IFG Companies

Risk Management Actuary

Alpharetta, GA · On-site

$150K - $200K/yr

The Risk Management Actuary ("RMA") plays a key role in supporting IFG Companies' enterprise risk ... IFG Companies offers competitive compensation and benefits, currently including medical, dental ...

Jj

Data and Risk Mgmt Sr QS Specialist

Athens, GA · On-site

Manages the local risk register and maintains active involvement in reporting out and up to the ... medical device / life sciences and / or other GxP regulated industry. * Experience using data ...

CorDx

Senior Production Manager

Alpharetta, GA

... management within the medical device or healthcare manufacturing industry , driving efficiency ... Ensure documentation, production procedures, and risk management align with FDA and ISO 13485 ...

CorDx

Senior Production Manager

Alpharetta, GA · On-site

... management within the medical device or healthcare manufacturing industry , driving efficiency ... Ensure documentation, production procedures, and risk management align with FDA and ISO 13485 ...

CorDx

Quality Assurance Manager

Alpharetta, GA · On-site

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Risk Management & Continuous Improvement * Identify quality risks and implement proactive ...

CorDx

Quality Assurance Manager

Alpharetta, GA

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Risk Management & Continuous Improvement * Identify quality risks and implement proactive ...

CorDx

Quality Assurance Manager

Alpharetta, GA · On-site

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Risk Management & Continuous Improvement * Identify quality risks and implement proactive ...

Avanos Medical

Quality Engineer - Sr

Alpharetta, GA · On-site

$84K - $114K/yr

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions ... Support inputs into Risk Management Files (ISO 14971) based on post-market data trends.

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Medical Device Risk Management information

See Gainesville, GA salary details

$48K

$104K

$158.5K

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

As of Sep 10, 2026, the average yearly pay for medical device risk management in Gainesville, GA is $104,021.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,900.00 and $120,300.00 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 Gainesville, GA look for?

The top searched job categories for Medical Device Risk Management jobs in Gainesville, GA are:

What cities near Gainesville, GA are hiring for Medical Device Risk Management jobs?

Cities near Gainesville, GA with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you

Data and Risk Mgmt Sr QS Specialist

Athens, GA • On-site

Johnson and Johnson
See more jobs at Johnson and Johnsonexternal

$95K/yr

Full-time

Retirement, PTO

Posted 14 days ago

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Quality Systems
Job Category:
Professional
All Job Posting Locations:
Athens, Georgia, United States of America
Job Description:
The Senior Quality Systems Specialist - Data Integrity and Risk Management proactively contributes to risk identification, assessment, mitigation, governance, and reporting.
Ensures communication and reporting efforts follow global and local requirements to produce value-added, actionable risk analytics and governance information.
Oversees the local risk assessment periodic review program and ensures site adherence to periodic review schedules.
Manages the local risk register and maintains active involvement in reporting out and up to the platform and risk management Community of Practice forums.
Assists in the implementation of Risk Management Systems designed to identify, eliminate or reduce, and insure against potential risks to the organization.
Assesses and improves quality analysis review process to identify control deficiencies, and to ensure the risk management process is operating effectively and efficiently.
Leads and conducts complex risk assessments under minimal supervision, leading and ensuring proper execution and utilization of appropriate risk models.
Essential Job Duties and Responsibilities:
  • Responsible for identifying, assessing, controlling and mitigating risks to ensure patient safety and product safety, quality, and regulatory compliance (e.g., ICH Q9) throughout the product lifecycle.
  • Provides accountability and ownership of the local site risk register including escalating to the global platform based on risk level. Responsible for ensuring that site level risks are appropriately classified.
  • Supports the digitalization and automation of quality risk management data to drive data insights, and process innovation.
  • Documents business critical issues and risks following integrated risked-based decision making.
  • Leads risk assessment sessions where required and as part of change management.
  • Partners with data analytics team(s) and leverages data analytics tools to create dashboards, reports, and any additional ad-hoc requests impacting data integrity and risk management.
  • Identification of trends and opportunities for improvements through analysis of complex datasets including monitoring for Systemic Issues and Significant Quality Issues requiring escalation.
  • Collaborate cross-functionally to determine and address data and reporting needs.

Minimum Qualification(s):
  • A minimum of a bachelor's degree required (preferred: Data Integrity, Risk Management, Computer Science, Engineering Science or equivalent)
  • Two or more years of experience mining and assessing data as a data analyst or similar role
  • Hands-on experience with executing various risk assessment methodologies, tools and application of risk-based decision-making.
  • Quality experience & applied knowledge of cGMPs including 21 CFR part 11 / Annex 11, ICH Q7 and Q9.
  • A minimum of (2) years of experience in Quality Assurance within the pharmaceutical / medical device / life sciences and / or other GxP regulated industry.
  • Experience using data analytics / visualization tools (e.g., Domo, Tableau, Looker, Qlik, Microsoft Power BI, Python) in data analysis; Solid understanding of data structures and transformations.
  • Expert with Microsoft Excel or other business intelligence / analytical tools

Preferred:
  • Skilled in analytical and critical thinking used in problem solving techniques.
  • Strong ability to prioritize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with other team members that may impact timely completion.
  • Works effectively with people that have diverse work styles, talents and ideas.
  • Excellent communication skills.

Required Skills:
Preferred Skills:
Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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