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Medical Device Risk Management Jobs in Fort Mill, SC

... Enterprise Risk Management is responsible for overseeing and coordinating the organization ... Health benefits - Medical, Dental, Vision * Personal and Vacation Time * Retirement & Savings Plan ...

Sales Manager - Medical Device

Charlotte, NC ยท On-site

$75K - $100K/yr

HIRE-IQ is recruiting a full-time Sales Manager for a well-established medical device company. The ... Maintain accurate and current records within the company's CRM system * Participate in national and ...

Senior Process Engineer

Huntersville, NC

$97K - $126K/yr

Process Engineer- MEDICAL DEVICE EXPERIENCE REQUIRED- RELOCATION OFFERED This Process Engineer role ... Lead process-related risk management activities, including process risk assessments, and support ...

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We are seeking a Medical Device Engineer with developing to advanced expertise in expanded PTFE ... Participate in design and process risk management activities (e.g., FMEA, material risk assessments)

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We are seeking a Medical Device Engineer with developing to advanced expertise in expanded PTFE ... Participate in design and process risk management activities (e.g., FMEA, material risk assessments)

Senior Process Engineer

Huntersville, NC ยท On-site

$97K - $126K/yr

... of medical device product(s) including determination of process flow, fixture/tooling development ... related risk management activities including process FMEAs, as well as support application and ...

Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR Part 820 * Familiarity with applicable medical device standards including ISO 10555, ISO 11070, ISO 5840, ISO ...

Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR Part 820 * Familiarity with applicable medical device standards including ISO 10555, ISO 11070, ISO 5840, ISO ...

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Medical Device Risk Management information

See Fort Mill, SC salary details

$45.3K

$98K

$149.4K

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

As of Jul 5, 2026, the average yearly pay for medical device risk management in Fort Mill, SC is $98,030.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,100.00 and $113,400.00 per year, depending on experience, location, and employer.

Is risk management a good career?

Risk management in the medical device industry involves identifying and mitigating potential safety and compliance issues, which is essential for product development and regulatory approval. It requires strong analytical skills, knowledge of standards like ISO 14971, and often involves collaboration with engineering and quality teams. The field offers opportunities for growth, specialization, and a stable career path due to the importance of safety in healthcare products.

What is the highest paying risk management job?

In the field of medical device risk management, senior roles such as Risk Management Directors or Chief Risk Officers typically have the highest salaries, often exceeding six figures. These positions require extensive experience, certifications like ISO 14971, and leadership skills, reflecting their strategic importance and responsibility within organizations.

How much does a risk manager get paid?

A medical device risk management professional's salary typically ranges from $70,000 to $130,000 annually, depending on experience, certifications, and location. Senior risk managers or those with specialized skills can earn higher salaries, especially in regulated environments requiring knowledge of ISO 14971 and risk assessment tools.

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 risk management in the medical device industry?

Risk management in medical device risk management involves identifying, assessing, and controlling potential hazards associated with medical devices to ensure patient safety and regulatory compliance. Professionals in this field use tools like risk analysis and failure mode effects analysis (FMEA) and often require knowledge of standards such as ISO 14971. Effective risk management is essential throughout the device lifecycle, from design to post-market surveillance.

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 popular job titles related to Medical Device Risk Management jobs in Fort Mill, SC? For Medical Device Risk Management jobs in Fort Mill, SC, the most frequently searched job titles are:
Medical Device Sales Representative - 77

Medical Device Sales Representative - 77

Rep-Lite

Charlotte, NC โ€ข On-site

$70K - $100K/yr

Full-time

Posted 11 days ago

Be an early applicant


Job description

Medical Device Sales Representative โ€“ Advanced Surgical Technologies

North Carolina territory | Field-Based | Surgical & Procedural Medicine

About the Opportunity

We are partnering with an innovative, rapidly growing medical device company that is expanding its commercial team throughout North Carolina. We are seeking a high-performing Medical Device Sales Representative to drive adoption of advanced surgical technology across hospitals, health systems, and ambulatory surgery centers throughout the Charlotte market.

This role is ideal for a sales professional who thrives in procedural environments, enjoys working alongside physicians and clinical teams, and wants the opportunity to make a significant impact within a high-growth organization. You'll have direct visibility with leadership, meaningful territory ownership, and the ability to influence the company's growth strategy.

What You'll Do
  • Manage and grow a high-potential territoryย 
  • Drive new business development while expanding utilization within existing accounts
  • Build strong relationships with surgeons, physicians, electrophysiologists, cardiovascular specialists, OR leadership, and key clinical stakeholders
  • Provide clinical support during procedures and product evaluations
  • Lead product trials, physician training initiatives, and technology conversions
  • Develop territory business plans and execute strategies to exceed revenue objectives
  • Partner cross-functionally with clinical, marketing, and leadership teams to accelerate growth
  • Become the trusted resource for customers adopting innovative procedural technologies
Ideal Candidate Profile

We're interested in candidates who have successfully sold or supported technology in complex procedural environments and understand how to navigate hospital-based selling.

Required Qualifications
  • 3+ years of medical device salesย experience
  • Demonstrated success selling into hospitals, health systems, or ambulatory surgery centers
  • Proven ability to develop new business and expand existing accounts
  • Experience supporting physicians and clinical teams in procedural settings
  • Strong consultative selling and relationship-building skills
  • Bachelor's degree preferred
Highly Preferred Experience

Experience with one or more of the following:

  • Advanced energy-based surgical cutting or electrosurgical technologies
  • Cardiovascular medical devices
  • Electrophysiology (EP) technologies and procedures
  • Minimally invasive surgical technologies
  • Interventional or catheter-based therapies
  • OR-focused surgical specialties and procedural medicine

Additional consideration will be given to candidates with:

  • Startup, emerging-growth, or high-growth medical device company experience
  • Clinical backgrounds such as RN, CV Tech, Surgical Technologist, or related procedural experience
  • Experience launching new technologies or entering new markets
  • Strong physician relationship networks within the territory
Why Join
  • Opportunity to join a rapidly growing medical device company during a pivotal stage of expansion
  • Significant territory growth potential and market opportunity
  • High visibility with executive leadership and faster decision-making
  • Innovative technology solving meaningful clinical challenges
  • Entrepreneurial culture with autonomy and ownership
  • Competitive compensation package with strong earnings potential
  • Career advancement opportunities as the organization continues to scale

If you're passionate about procedural medicine, enjoy working alongside physicians, and want to help build a growing business with innovative technology, we'd love to connect.

Rep-Lite receives a large volume of resumes for each position and regretfully cannot respond to each application.

If we have an interest in speaking with you further, we will email a request for a video interview. Sometimes these emails end up in spam/junk so please make sure you are checking them periodically; the sending domain will be @applytojob.com.

Thank you for your interest in Rep-Lite and good luck in your search!

***โ€œColorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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