Regulatory Compliance Specialist - ISMS

Company Description

Improving healthcare through innovative technology is at the core of Intelerad’s work. Our scalable medical imaging platform connects clinicians to a powerful imaging ecosystem that is fast, smart, and tapped into the data they need, no matter their location. We’re focused on delivering a best-in-class medical image management solution that improves provider efficiency, decreases the cost of healthcare, and improves the overall health of populations.  

Intelerad offers one of healthcare’s most comprehensive imaging and analytics platforms. Headquartered in Raleigh, NC and Montreal, Intelerad has nearly 700 employees located in offices across six countries. The company empowers nearly 2,000 healthcare organizations around the world with the speed, scalability, and simplicity needed to increase business performance while, most importantly, improving patient outcomes. Intelerad’s modern enterprise solutions have been acknowledged by a Best in KLAS recognition, ranking #1 for PACS Asia/Oceania in the 2021 Best in KLAS: Global Software (Non-US) report. To learn more, visit intelerad.com and follow Intelerad on LinkedIn and Twitter.

Job Description

Job Summary:

The Regulatory Compliance Specialist is responsible for improving and maintaining certifications such as ISO 13485 and ISO 27001 as well as other standards and applicable laws. The Regulatory Compliance Specialist works with the Privacy Compliance Manager and Quality Manager to ensure regulations requirements are integrated into followed processes and procedures while improving our current management system. This Regulatory Compliance Specialist also provides guidance, support and training to the rest of the organization.

Supervisory Responsibilities:

• None

Duties/Responsibilities:

• Ensure management of Corrective and preventative actions (CAPAs): issue, assign, verify implementation and effectiveness within set timeframes

• Ensure maintenance of the QMS/ISMS documentation and proper retention of documents and records

• Participate in activities related to adverse events and recalls (reports, notification, follow-ups)

• In collaboration with the privacy compliance manager, follow-up on information security or privacy incidents, and propose improvement solutions to prevent breaches, events and weaknesses

• Supervise and coordinate external QMS and ISMS audits 

• Conduct and/or coordinate QMS and ISMS internal audits to ensure compliance to legal, regulatory and ISO standards requirements 

• Provide advice and take action, where necessary, in response to audit findings and recommendations in respect of information security

• When required, coordinate third-party audits to assess if the appropriate controls are in place to protect the organization’s information

• Oversee and participate in the creation of ISMS and QMS training material and provide such training when required

• Create, update, and/or review QMS and ISMS documents, in collaboration with process owners

• Analyze and find   solutions to improve our QMS and ISMS efficiency

• Coordinate and participate in internal process improvement projects

• Work on special projects with regard to the organization’s orientations (reports, statistics, research, etc)

• Collaborate with the Privacy and Quality managers to integrate new regulations requirements into current processes

Qualifications

Required Experience/Skills:

• Bachelor’s degree in Business, Quality Management or equivalent  

• 3+ years of experience with a quality management system 

• Knowledge and/or experience of HIPAA and Privacy laws

• Knowledge of ISO 13485, ISO 9001 and/or 27001

• Knowledge of MS Office, Google Suite and Visio (or similar workflow tool)

• Strong verbal and written communication skills in English 

• Strong technical aptitude and a quick learner with the ability to understand medical imaging

• Excellent analytical, research, organizational and planning skills

Additional Information

All applicants meeting minimum qualifications will be required to complete a 30 minute online assessment as part of your application.
 

Intelerad and Ambra Health Combine to Form the Global Industry Leader in Cloud PACS and Enterprise Imaging
 

Intelerad Partners with Strategic Radiology to Bring Innovative Medical Image Management Solutions to More than 1,300 Radiologists Across the US

Meet Intelerad’s Leadership Team: https://www.intelerad.com/en/about/leadership-team/

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