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Sr. QA/RA Compliance Specialist

Location
Vancouver, BC
Details
Full Time
5 days ago

Today, as many as 25 million medical professionals globally do not 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 quality, easy-to-use and affordable ultrasound available to all medical professionals in every specialty. Our developers were the brains behind the first PC-based platform. Now, they’re reinventing ultrasound with AI. By making Clarius your next career move, you’re joining a talented, innovative and collegial team.  

 

Want to make a global impact while driving regulatory and quality compliance ? As a Sr. QA/RA Compliance Specialist you will be directly responsible for obtaining regulatory registrations for Clarius’ products in new and emerging global markets, while contributing to making a positive impact on healthcare and patients globally. This hybrid QA/RA role offers a unique opportunity to be directly involved with both quality and regulatory aspects of the organization.  As a Sr. QA/RA Compliance Specialist you will be directly responsible for 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. This role offers the right candidate the opportunity to utilize and develop their technical and leadership skills while having a positive impact on healthcare globally. 

Reporting to the QA/RA Manager (RA Director during parental leave), the Sr. QA/RA Compliance Specialist will be primarily responsible for the implementation and maintenance of the QMS, for obtaining and maintaining global regulatory registrations, and for supporting internal and external audits. 

We’re growing fast and we need your help. Come be part of this feel-good local medical technology success story. Take your career to the next level as part of Clarius’ QA/RA compliance team. 

The Job: 

  • Submit and maintain regulatory registrations for Oceania, Asia, Middle East, Africa, and South America and support regulatory submissions for North America and the EU 
  • Create and maintain Quality System Procedures for compliance with FDA 21 CFR Part 820, Health Canada, MDSAP, EU MDR and ISO 13485 requirements 
  • Communicate directly with internal and external parties/stakeholders (e.g., R&D, sales, logistics, manufacturing, marketing, suppliers, distributors, auditors, regulatory agencies) 
  • Support internal and external audits with the potential of serving as the Management Representative for the organization and assist with annual Management Review Meetings 
  • Support product Post-Market Surveillance/ Vigilance activities and submit reports to external agencies as needed
  • Support Quality with Monthly Monitoring and Measurement Metric report  
  • Monitor the Non-conformance, Corrective Action and Preventive Action System 
  • Create DHF documents such as hardware / software validation plans and reports and assist in product Risk Management activities 
  • Provide QMS training to personnel at Clarius 
  • Responsible for Document Control and Records Management 

Our Ideal Candidate: 

  • Working knowledge of ISO 13485, MDSAP, EU MDR, FDA and Health Canada regulatory requirements 
  • Experience in creating and maintaining Quality System Procedures for compliance with FDA 21 CFR Part 820, Health Canada, MDSAP, EU MDR and ISO 13485 requirements 
  • Experience in internal auditing and leading and/or supporting external audits (e.g., MDSAP, ISO 13485, FDA, Health Canada, EU MDD, EU MDR) 
  • Experience in software and/or 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  
  • Experience in regulatory activities 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; 

 Qualifications: 

  • Minimum of 5 years of Regulatory Affairs / Quality Assurance experience in the medical device industry 
  • Post-secondary education in Quality Management, Regulatory Affairs, Sciences, or a related field 
  • Lead auditor training an asset 

 

What We Offer:

Clarius is pleased to offer our team a competitive salary, full benefits with an HSA, a monthly transportation allowance and competitive vacation.  

If you are motivated by making an impact, then Clarius Mobile Health is your opportunity to work on a product that makes a difference in peoples’ lives. You will be working within a team of industry leaders and innovators to achieve this impact. Join our team if you are looking for a mission driven company that is creating a paradigm shift in the medical field. We look forward to working with you. 

Category
Biotechnology