19 Aug
|
Assurant Canada
|
Winnipeg
19 Aug
Assurant Canada
Winnipeg
A Career at ClariusToday, 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.A Career at ClariusToday, 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 RoleWe are seeking a detail-oriented and driven Compliance Specialist to join our QA/RA team on a 12 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.Your Responsibilities IncludeCompliance Monitoring: Monitor changes in relevant regulations, standards, and guidance documents to ensure ongoing compliance with FDA, ISO, and other regulatory bodies.Quality Management System (QMS) Support: Help maintain and update Clarius' Quality Management System in accordance with ISO 13485 and other applicable standards.Internal Audits: Assist in conducting and documenting internal audits aligned with QMS requirements.Non‑Conformance Reporting: Participate in and monitor the implementation of corrections and preventive actions (CAPAs).Training Support: Assist in the development and delivery of compliance and quality training programs for company personnel.Process Monitoring: Support cross-functional collaboration and monitor the implementation of Clarius' compliance processes.Regulatory Intelligence: Support the compliance team in researching and analyzing regulatory trends, providing insights and recommendations for proactive compliance strategies.Continuous Improvement: Participate in process improvement initiatives to enhance the efficiency and effectiveness of the compliance functionYour Experience So FarISO 13485:2016 Internal Auditor Certification requiredPost‑secondary education preferably in Quality Management, Sciences,
or a related fieldUnderstanding of 21 CFR 820 and/or ISO 13485 standards0-2 years of experience in Quality Management Systems or a related field within healthcare or medical device industryStrong attention to detail and organizational skillsExcellent written and verbal communication skillsAbility to work independently and collaboratively in a team environmentProficiency in Microsoft Office SuiteAbility to manage multiple tasks and meet deadlinesCommutable to office locationPrior experience conducting internal audits, advantageousFamiliarity with regulatory submission processes, advantageousExperience with QMS software platforms, advantageousBackground in life sciences, pharmaceutical, or medical device sectors, advantageous.Location and Compensation:This is a temporary full time contract, minimum of 12 months. Based in Vancouver, BC, with a hybrid work option. The salary range for this role is set at $65,000 - $70,000.More Reasons To ConsiderFlexible Hours & Hybrid ModelEmbrace work-life balance with flexible schedule and a hybrid work model that suits your lifestyle.Volunteer DaysMake a difference with paid volunteer days during working hours, supporting causes that matter to you.WorkspaceOur modern office features sit/stand desks, various health & wellness facilities, a stocked kitchen, outdoor amenities, on‑site daycare, enclosed parking, a free on‑site gym and close proximity to a SkyTrain station.Clarius Mobile Health is proud to be an Equal Opportunity Employer. We encourage applications from any qualified candidate regardless of ethnicity, religion, age, national origin, disability status, sexual orientation, gender identity or expression. Please let us know if you require any accommodations during the interview process.#J-18808-Ljbffr
📌 Alberta Reliability Standards (Ars) Cip Compliance Specialist - $61,500 - $64,000 A Year (Winnipeg)
🏢 Assurant Canada
📍 Winnipeg