What are the responsibilities and job description for the Risk Management Specialist position at Intellectt Inc?
Job Title: Risk Management SME
Location: Remote (Cincinnati, OH - 45227)
Duration: 6 Months (Contract)
Openings: 1
Position Overview:
We are seeking an experienced Risk Management Subject Matter Expert (SME) to join our Design Quality Assurance team. This role focuses on performing gap assessments, planning, and executing risk management and usability activities to align with EU MDR and relevant standards. As a key contributor, you will collaborate with cross-functional teams to enhance processes, ensure compliance, and drive innovation in medical device development and post-market surveillance.
Key Responsibilities:
Risk Management & Usability:
- Perform in-depth gap assessments of existing usability and risk management documentation against ISO 14971:2019, EU MDR requirements, and IEC 62366-1:2015.
- Lead and guide the remediation process, providing expertise and ensuring compliance with regulatory standards.
Process Development & Continuous Improvement:
- Develop and implement robust processes, procedures, tools, and technologies to enhance risk management practices.
- Define and monitor key performance indicators (KPIs) to evaluate and improve the risk management system.
Post-Market Surveillance Support:
- Collaborate with post-market surveillance teams to create Health Impact Assessments (HIAs) and Health Hazard Evaluations (HHEs) for product safety and compliance.
Cross-Functional Collaboration:
- Partner with teams from Design, Regulatory Affairs, Medical Affairs, and Manufacturing Engineering to ensure alignment and successful execution of risk management initiatives.
Required Qualifications:
- Education:
- Bachelor’s Degree in Engineering (Mechanical, Chemical, Biomedical, or Electrical).
- Experience:
- 5-7 years of experience in the medical device industry with a strong focus on Risk Management.
- Expertise in the application of ISO 14971:2019, EU MDR, and IEC 62366-1:2015 standards.
- Hands-on experience in applying statistical methods to calculate probabilities of hazardous situations (p1) and risk analysis.
- Skills:
- Proficiency in Minitab or similar statistical tools.
- Advanced understanding of Usability Engineering and Risk Management best practices.
- Strong communication skills (written and verbal).
- Additional Requirements:
- Experience working on Risk Management processes after 2020.
- Ability to work during normal business hours.
Preferred Qualifications:
- Familiarity with post-market surveillance processes and regulatory compliance requirements.
- Demonstrated expertise in developing and implementing Risk Management tools and processes.
- Strong analytical and problem-solving skills with the ability to assess and resolve complex issues.
Why Join Us?
This role offers a unique opportunity to leverage your expertise in Risk Management within the medical device industry. By joining our team, you will play a vital role in ensuring patient safety, regulatory compliance, and driving continuous improvement in innovative medical technologies.
Work Environment:
- Fully remote role with collaborative opportunities across global teams.
- Flexibility to work standard business hours.
