Regulatory Compliance Expert
7 days ago
Clarius Mobile Health is a pioneering company in the medical imaging industry, dedicated to making high-performance, affordable, and easy-to-use solutions accessible globally. Our mission is to improve patient care and reduce healthcare costs by delivering innovative products powered by artificial intelligence and connected to the cloud.
We're a team of over 140 talented individuals who are passionate about innovation, collaboration, and excellence. Joining us means becoming part of a community that includes thousands of physicians worldwide who trust Clarius to deliver better patient care.
Our Commitment to ExcellenceWe're committed to maintaining the highest standards of quality and regulatory compliance. Our Regulatory Compliance Specialist will play a critical role in ensuring our products meet all necessary regulatory requirements and standards.
Your Role and ResponsibilitiesYou'll be responsible for:
- Compliance Monitoring: Staying up-to-date with regulatory updates from FDA, ISO, and other relevant bodies to maintain Clarius' full compliance.
- Quality Management System (QMS) Support: Contributing to the maintenance and continuous improvement of our QMS to meet ISO 13485 and other essential standards.
- Internal Audits: Assisting in internal audit processes to ensure compliance across all departments.
- Non-Conformance Reporting: Participating in corrective action planning and supporting implementation efforts.
- Deliver Training: Contributing to creating compliance training programs.
- Coordinate Efforts: Working across teams to ensure smooth process implementations.
- Gather Regulatory Insights: Researching and providing insight into emerging regulatory trends.
- Drive Improvement: Supporting initiatives to streamline our compliance efforts.
To succeed in this role, you'll need:
- Post-secondary education in Quality Management, Sciences, or a related field.
- 0-2 years of experience in Quality Management System or a related field within the healthcare industry.
- 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.
This is an exciting opportunity to launch your career in medical device compliance with a leading company in the industry. You'll have the chance to gain hands-on experience, build skills that make a real impact, and contribute directly to our mission.
What We OfferWe offer a competitive salary range of $60,000 - $70,000, based on location and experience. You'll also enjoy:
- Flexible hours and a hybrid work model that suits your lifestyle.
- Benefits from day one, including comprehensive benefits packages.
- Paid volunteer days during working hours to support causes that matter to you.
- Professional development program with financial support for programs, seminars, conferences, and courses.
- Modern office facilities featuring sit/stand desks, health & wellness facilities, a stocked kitchen, outdoor amenities, on-site daycare, enclosed parking, a free on-site gym, and proximity to public transportation.
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