Compliance Specialist, Clarius Mobile Health
$60-70k
High-definition ultrasound imaging
Job no longer available
High-definition ultrasound imaging
101-200 employees
Job no longer available
$60-70k
101-200 employees
Company mission
To make accurate, easy-to-use and affordable ultrasound tools available to all medical professionals.
Role
Who you are
- 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
What the job involves
- Clarius Mobile Health Corp. is looking for a detail-oriented and driven Medical Device Compliance Specialist to join our QA/RA team
- 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
- This role is your chance to build a solid foundation in medical device compliance within a supportive, growth-focused environment
- 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
Our take
Ultrasound technology is often expensive, difficult to use and prone to error. Clarius is setting out to solve these problems by democratizing access to high-quality ultrasound tools.
Clarius's scanners are light, handheld, wireless and connect to Android and iOS devices, making them far more convenient than bulky, traditional scanners. This has allowed Clarius to maintain a distinct market position. Since its launch, the company's devices have carried out over two million scans in over 50 countries. What's more, a recent influx of funding will allow them to scale these numbers.
Off the back of $15.7 million of funding in 2022, Clarius released a new AI-powered, HD model in 2023. This will enable it to build on its current progress and to expand its customer base, which will be a vital part of its continued success.
Freddie
Company Specialist at Welcome to the Jungle
Insights
Company
Funding (last 2 of 4 rounds)
Dec 2015
$16.5m
SERIES B
Jun 2014
$6.5m
SERIES A
Total funding: $24.1m
Company benefits
- Competitive Benefits and Vacation
- Competitive Salary
- Commute/Home Office Allowance
- Flexible Hours & WFM
- Professional Development
- Volunteer Days
Company values
- Trust - Trevor Hanson, Director of Software Engineering was recognized as someone who “can always be relied on to follow through on commitments and deliver quality work”. Peers see Trevor as someone who will “go above and beyond” and “demonstrate a thorough concern for all areas involved”.
- Collaboration - Sarah Leblanc, Customer Support Tech, has a “great strength in building relationships” with our customers and team members across the organization. She brings ideas to the table, shares her knowledge and is “great at encouraging and motivating others”.
- Innovation - Eric Choy, Quality Engineering Manager, “brings innovation into the Quality world to make big improvements”. He has implemented many improvements that have “saved countless hours in our manufacturing department”. Eric “brings people together and draws from their expertise to continuously improve”.
Company HQ
Renfrew-Collingwood, Vancouver, BC
Articles
Leadership
Laurent Pelissier
(CEO)Was Founder and CEO of Ultrasonix, and Director of the Medical Device Development Centre (MDDC). Is the current President of LPMV.
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