Regulatory Compliance Expert
4 days ago
A Career at Clarius
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 joining our team, you'll become part of a community that includes thousands of physicians worldwide who use Clarius to deliver better patient care. You'll also be part of a highly collaborative environment where talent, innovation, and teamwork thrive.
Your RoleAre you eager to launch a career in medical device compliance? We're looking for a detail-oriented and driven Medical Device Compliance Specialist to join our QA/RA team. In this role, you'll actively support compliance efforts to ensure Clarius meets all necessary regulatory requirements and standards.
You'll join Clarius Mobile Health's QA/RA team, where you'll contribute directly to our mission by ensuring our products meet high regulatory standards. This is an ideal opportunity to gain hands-on experience in the fast-paced medical device industry, building skills that make a real impact.
Responsibilities Include:- Compliance Monitoring: Stay on top of updates to regulations and standards from FDA, ISO, and other regulatory bodies, helping keep Clarius in full compliance.
- Quality Management System (QMS) Support: Help maintain and continuously improve Clarius' QMS to meet ISO 13485 and other essential standards.
- Internal Audits: Assist in internal audit processes, ensuring compliance across all departments.
- Non-Conformance Reporting: Participate in corrective action planning and support implementation efforts.
- Deliver Training: Contribute to creating compliance training programs.
- Coordinate Efforts: Work across teams to ensure smooth process implementations.
- Gather Regulatory Insights: Research and provide insight into emerging regulatory trends.
- Drive Improvement: Support initiatives to streamline our compliance efforts.
- Post-secondary education preferably in Quality Management, Sciences, or a related field.
- 0-2 years of experience in Quality Management System or related field within the healthcare industry.
- Understanding of 21 CFR 820 and/or ISO 13485.
- Strong attention to detail and organization 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.
Based in Vancouver, BC, with a hybrid work option. The estimated salary range for this role is $65,000 - $75,000 annually.
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