Compliance Specialist

Clarius Mobile Health•Vancouver, BC

7d•CA$65,000 - CA$70,000•Hybrid

About The Position

A Career at Clarius 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 140+ people who are talented, innovative, and highly collaborative. You’re also joining a community that includes thousands of physicians worldwide who use Clarius to deliver better patient care! And you’re joining a thrice-certified Great Place to Work! Your Role We are seeking a detail-oriented and driven Compliance Specialist to join our QA/RA team on a 12 to 18 month contract covering a maternity leave absence. In this entry-level role, you will support the compliance team in ensuring that Clarius Mobile Health meets all relevant regulatory requirements and standards. This position is scoped entirely to compliance activities and does not include Regulatory Affairs (RA) responsibilities such as regulatory submissions, filings, or RA-specific trend analysis. You'll gain hands-on experience in medical device compliance within a supportive, growth-focused environment.

Requirements

ISO 13485:2016 Internal Auditor Certification required
Post-secondary education preferably in Quality Management, Sciences, or a related field
Understanding of 21 CFR 820 and/or ISO 13485 standards
0-2 years of experience in Quality Management Systems or a related field within healthcare or medical device industry
Strong attention to detail and organizational skills
Excellent written and verbal communication skills
Ability to work independently and collaboratively in a team environment
Proficiency in Microsoft Office Suite
Ability to manage multiple tasks and meet deadlines
Commutable to office location

Nice To Haves

Prior experience conducting internal audits, advantageous
Familiarity with regulatory submission processes, advantageous
Experience with QMS software platforms, advantageous
Background in life sciences, pharmaceutical, or medical device sectors, advantageous.

Responsibilities

Monitor changes in relevant regulations, standards, and guidance documents to ensure ongoing compliance with FDA, ISO, and other regulatory bodies.
Help maintain and update Clarius' Quality Management System in accordance with ISO 13485 and other applicable standards.
Assist in conducting and documenting internal audits aligned with QMS requirements.
Participate in and monitor the implementation of corrections and preventive actions (CAPAs).
Assist in the development and delivery of compliance and quality training programs for company personnel.
Support cross-functional collaboration and monitor the implementation of Clarius' compliance processes.
Support the compliance team in researching and analyzing regulatory trends, providing insights and recommendations for proactive compliance strategies.
Participate in process improvement initiatives to enhance the efficiency and effectiveness of the compliance function.