Quality Assurance and Compliance Specialist
13 hours ago
Corti is a pioneering healthcare company that has built the world's premier AI assistant for healthcare providers. We're seeking an experienced Quality Assurance and Compliance Specialist to join our team in Copenhagen.
About the JobThis is a full-time position starting as soon as possible, reporting directly to the VP of Governance and Market Access. The successful candidate will ensure that our products and services meet the highest standards of quality and compliance, while also leading the medical device application process in several markets.
Key Responsibilities:- Develop and maintain quality management systems to ensure compliance with relevant regulations and standards.
- Conduct risk assessments and develop risk management strategies to mitigate potential hazards.
- Implement and monitor processes for continuous quality improvement.
- Serve as the primary point of contact for regulatory affairs and compliance.
- Bachelor's degree in a relevant field, such as quality management or life sciences, required.
- At least 2 years of experience in quality assurance, regulatory affairs, or a related field.
- Familiarity with industry regulations and standards, including MDR and FDA regulations.
- Experience with conducting risk assessments and developing risk mitigation strategies.
- Strong communication and project management skills.
- A competitive salary range of $120,000 - $150,000 per year, based on qualifications and experience.
- A dynamic and collaborative work environment.
- The opportunity to work on cutting-edge projects that are revolutionizing the healthcare industry.
- A comprehensive benefits package, including health insurance and paid parental leave.
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IT Quality and Compliance Training Specialist
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Biologics Quality Assurance Specialist
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