Clarius Mobile Health Hiring for RA/QA Compliance Specialist at Remote Full Time

Today, as many as 25 million medical professionals globally don’t have access to medical imaging, which is proven to improve patient care and reduce healthcare costs. That’s why we’re on a mission to make medical imaging accessible everywhere by delivering high-performance, affordable, and easy-to-use solutions powered by artificial intelligence and connected to the cloud.

By making Clarius your next career move, you’re joining a team of 130+ people who are talented, innovative, and highly collegial. You’re also joining a community that includes thousands of physicians worldwide who use Clarius to deliver better patient care – nearly two million high-definition exams have been performed using Clarius! And you’re joining a remarkable team that’s hitting it out of the park.

Want to make a global impact while driving regulatory and quality compliance initiatives within Clarius? As our QA/RA Compliance Specialist, you will be responsible for supporting regulatory submissions and registrations for Clarius’ products in new and emerging global markets, while contributing to making a positive impact on healthcare and patients globally. This hybrid RA role offers a unique opportunity to be involved with both quality and regulatory aspects of Clarius. As a QA/RA Compliance Specialist you will be responsible for supporting pre-market regulatory activities such as obtaining new regulatory registrations in various global markets/jurisdictions while maintaining existing product registrations globally, post-market surveillance/ vigilance activities, and maintaining and continuously improving the Quality Management System (QMS) to ensure continuous compliance with regulatory requirements.

This role offers you, as the right candidate, the opportunity to utilize and develop their technical skillset through continuous learning tied to this role while helping the organization expand into new markets by securing regulatory registrations, ensuring quality compliance and making a positive impact on healthcare globally. You will Support new regulatory registrations/submissions for Oceania, Asia, Middle East, Africa, South America, North America and the EU, and support maintenance of existing registrations. You will also support internal and external audits and assist with annual Management Review Meetings and monitor the Non-conformance, Corrective Action and Preventive Action System.

Reporting to the RA Director, the RA/QA Compliance Specialist will be primarily responsible for support with the implementation and maintenance of the QMS, for support with obtaining and maintaining global regulatory registrations, and for supporting internal and external audits.

You bring

Minimum 2 years of Regulatory Affairs/ Quality Assurance/ Compliance experience in the medical device industry

Post-secondary education (e.g., Bachelor of Science, Advanced Diploma) in the Sciences, Engineering or a related field is desirable

Post-graduate education/training in Regulatory Affairs/Quality Assurance/Compliance is desirable

Internal auditor training an asset

Working knowledge of ISO 13485, MDSAP, EU MDR, FDA and Health Canada medical device regulatory requirements

Experience in creating and maintaining Quality System Procedures for compliance with FDA 21 CFR Part 820, Health Canada, EU MDR, MDSAP and ISO 13485 requirements

Experience with internal auditing and supporting external audits (e.g., MDSAP, ISO 13485, FDA, Health Canada, EU MDD, EU MDR)

Experience in software and/or medical device manufacturing environments, including knowledge of relevant standards (e.g., ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 62366, etc.)

Experience in technical writing (e.g., creating product user manuals, report writing)

Experience with an electronic PLM system

Familiarity with medical device regulatory submissions and knowledge of regulatory requirements across various jurisdictions such as EU, US, Canada, Australia, Asia, Middle East, South America

Self-motivated with strong written and verbal communication skills, excellent interpersonal skills, and collaborative

Strategic, analytical, focused, organized, detailed, continuous learner with a strong desire to meet and exceed expectations

Flexible with the ability to work under tight deadlines while managing multiple tasks/projects concurrently