A Risk Management Subject Matter Expert is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery. Remote work. The Risk Management Subject Matter Expert (SME) leads and supports risk management activities in the medical device industry, ensuring compliance with ISO 14971:2019, EU MDR, and IEC 62366-1:2015, while guiding cross-functional teams, developing processes, and implementing key performance metrics.
location: Remote, Remote
job type: Contract
salary: $61.75 - 86.26 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Perform gap assessments of usability and risk management documentation in relation to EU MDR requirements, ISO 14971:2019, and IEC 62366-1:2015.
- Provide leadership, expertise, guidance, and supervision throughout risk management remediation projects.
- Develop and implement efficient processes, procedures, practices, tools, and technologies for continuous improvement in risk management.
- Lead the development and implementation of key performance indicators (KPIs) and metrics for the risk management process.
- Support post-market surveillance teams by creating Health Impact Assessments and Health Hazard Evaluations.
- Working knowledge of ISO 14971:2019, MDR requirements, and IEC 62366-1:2015.
- Familiarity with statistical tools (e.g., Minitab) is a plus.
- strong communication skills, both verbal and written.
- Expertise in applying statistical techniques to calculate probabilities of hazardous situations (p1).
- Knowledge of industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools, and technology.
- Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical).
- 5-7 years of experience in the medical device industry, with expertise in applying Risk Management (ISO 14971:2019) for all classes of medical devices.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
