Intelerad Medical Systems · 7 hours ago
Regulatory Affairs & Quality Specialist
United States
Full-time
Remote
Mid Level
3+ years exp
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Responsibilities
Manage Corrective and Preventative Actions (CAPAs): issue, assign, verify implementation, and ensure effectiveness within set timeframes.
Maintain QMS documentation and ensure proper retention of documents and records.
Participate in activities related to adverse events and recalls, including reporting, notification, and follow-ups.
Supervise and coordinate external QMS audits.
Conduct and/or coordinate internal QMS audits to ensure compliance with legal, regulatory, and ISO standards.
Provide advice and take action in response to audit findings and recommendations regarding information security.
Coordinate third-party audits to assess the adequacy of controls in place to protect the organization’s information.
Oversee and participate in the creation of QMS training materials and provide training as required. Develop RAQ education programs and training sessions.
Participate in Quality meetings, set new metrics, and ensure existing metrics are gathered, analyzed, and acted upon. Collaborate with process owners to create, update, and review QMS documents.
Analyze and identify solutions to improve QMS efficiency. Coordinate and participate in internal process improvement projects.
Work on special projects related to the organization’s goals, including reports, statistics, and research.
Collaborate with Privacy and Quality Managers to integrate new regulatory requirements into current processes.
Participate in other projects as deemed necessary by Intelerad.
Align cross-functional processes and update SOPs.
Collaborate on supplier processes and RC board management.
Manage EUDAMED renewals and quality plans.
Qualification
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Required
3+ years of experience in quality management systems.
Bachelor’s degree in business, quality management, or related field (or equivalent).
Knowledge of ISO 13485, MDSAP, and EMDR requirements.
Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools).
Experience in the IT / software (SaaS) and/or medical device field (SaMD / SiMD)
Effective communication skills – English fluency.
Preferred
Working knowledge of common security standards such as SOC 2 and ISO 27001.
Company
Intelerad Medical Systems
Improving healthcare through innovative technology is at the core of Intelerad’s work.
501-1,000 employees
Funding
Current Stage
Late StageTotal Funding
$1.45MKey Investors
TA Associates
2023-01-17Series Unknown· $1.45M
2022-07-14Private Equity· undefined
2020-01-23Private Equity· undefined
Leadership Team
Mark Haney
Chief Technology Officer
Michael Ives
Chief Financial Officer
Recent News
2024-05-05
Globe Newswire
2024-04-24
Company data provided by crunchbase
