Regulatory Compliance Specialist

Over the last 20 years, Intelerad has grown into a leader of the medical imaging software industry. Our distributed solutions play a vital role in the delivery of healthcare across 11 time zones and 3 continents. We take pride in being a world-class healthcare solutions company with more than 400 employees and over 1,000 customer sites. Our workplaces encourage growth and professional development.

We are Intelerad. Join us if you want to be the best version of yourself and make a difference in healthcare.

The Regulatory Specialist is part of the regulatory team which is responsible for internal and external audit readiness for medical devices and information security management systems, including privacy. He/She will be in charge of identifying and implementing necessary to process changes to maintain ISO27001 and SOC2 type 2 certifications. The Regulatory Specialist will assist in proactively identify possible security and privacy concerns and inadequate systems that can negatively impact patients and customer satisfaction. The Regulatory Specialist will be responsible to lead improvement initiatives based on his/her findings. The ideal candidate combines knowledge of ISO 27001, HIPAA, PIPEDA and GDPR processes and quality/patient safety experience. Knowledge of MDSAP and ISO 13485 is also highly valued.

Responsibilities

• Understand and remain current on applicable InfoSec, PHI and privacy regulations in North America, Australia/NZ, Europe, and other geographies as required.

• Develops and maintains strong working relationship with internal teams, especially INFOSEC.

• Raise Intelerad privacy and security maturity level.

• Maintain up-to-date ISMS procedures and ensure they are being applied

• Gain an understanding of normal work process and any gaps that may exist between actual practice and established procedures as per privacy and InfoSec regulations.

• Participate in the definition and implementation of any new privacy and security policies, practices and controls

• Participate in external and internal ISMS audits and coordinate corrective and preventive actions

• Document outputs of post-marketing surveillance activities related to the uptime of cloud-based solutions and share it with appropriate stakeholders and follow-up on action items raised during these activities.

• Collaborate with internal teams to document trends and risks in order to develop, implement and lead initiatives that will improve Intelerad’s security and risk profile

• Ensure that documented processes are followed in a consistent, timely and efficient manner.

• Acts as technical expert on client-based security surveys

Requirements

• Bachelor’s degree in InfoSec, business, quality management or related fields (or equivalent certification).

• Minimum 3 years’ experience in information security management system(s)

• Knowledge of ISO-27001 and SOC 2 certification.

Assets

• Experience in the IT field, software development, medical and/or cloud hosting

• Working with ISO 13485

• Training in quality management and quality improvement

Skills

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

• Strong verbal and written communication skills in English

• Well-organized and project-oriented

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