Compliance Specialist

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 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 Include: Compliance 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 function Your Experience So Far: 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 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. 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 Consider: Flexible Hours & Hybrid Model: Embrace work-life balance with flexible hours and a hybrid work model that suits your lifestyle. Volunteer Days: Make a difference with paid volunteer days during working hours, supporting causes that matter to you. Workspace: Our 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. Requirements Post-secondary education, preferably in Quality Management, Sciences, or a related field. • Understanding of 21 CFR 820 and/or ISO 13485. • 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. • Required: ISO 13485:2016 internal auditor certification. • 0-2 years of experience in a Quality Management System or related compliance function, ideally within the healthcare industry.

The Compliance Specialist will support the QA/RA team by monitoring regulatory changes, maintaining the Quality Management System, and assisting with internal audits. They will also participate in non-conformance reporting, CAPA implementation, and provide training support to ensure company-wide compliance.

Candidates must have post-secondary education in a relevant field and an ISO 13485:2016 internal auditor certification. The role requires 0-2 years of experience in quality management or compliance, along with strong organizational and communication skills.

• Flexible hours • Hybrid work model • Paid volunteer days • Sit/stand desks • Health & wellness facilities • Stocked kitchen • Outdoor amenities • On-site daycare • Enclosed parking • Free on-site gym

• Gestion du tempsSouhaitée
• Souci du détailSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• ISO 13485
• 21 CFR 820
• Internal auditing
• Quality management systems
• Compliance monitoring
• CAPA
• Regulatory intelligence
• Process improvement
• Microsoft Office Suite
• Attention to detail
• Communication skills
• Time management
• Collaboration
• Regulatory Affairs
• Hybrid Model
• Cross-Functional Collaboration
• Healthcare Industry Knowledge
• Governance and Compliance Strategy
• Regulatory Intelligence
• Organizational Skills
• Ability To Meet Deadlines
• Medical Devices
• Title 21 Of The Code Of Federal Regulations
• Quality Management Systems
• Artificial Intelligence
• Computing Platforms
• Auditing
• Corrective And Preventive Action (CAPA)
• Continuous Improvement Process
• Innovation
• Internal Auditing
• ISO 13485 Standard
• Life Sciences
• Microsoft Office
• Pharmaceuticals
• Preventive Action
• Quality Management
• Safety Assurance
• Trend Analysis
• Verbal Communication Skills
• Process Improvement
• Detail Oriented

• Healthcare
• Science & Research
• Administrative
• Compliance Specialist
• Compliance Officer / Analyst
• Legal and Related Associate Professionals
• Compliance Officers

Formation minimale

Diplôme professionnel

Expérience minimale

0+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine