Would you like to be part of a dynamic and exciting team delivering high level performance that has a direct impact on the lives of cancer and rare disease patients worldwide? Join our growing team and use your exceptional technical and organizational skills to help us deliver on our mission of democratising Data-Driven Medicine. Our products are used by over a thousand healthcare institutions globally and provide world leading capabilities for the analysis of genomic, clinical, and imaging data.
Be part of our mission to disrupt the healthcare and democratize the data driven medicine! SOPHiA is looking for a Quality amp; Regulatory Assistant, to join the Global QA/RA organization.
Reporting to the SVP of Regulatory Affairs and Quality Assurance, you will support the Quality amp; Regulatory teams in meeting quality and regulatory requirements.
To succeed in this role you will have strong communication skills, desire to learn more about Quality amp; Regulatory requirements in in vitro diagnostics, an ability to work independently and with a team, and an analytical mindset to analyze data and draw conclusions.
Mission
- Support Regulatory Inspections or Quality Audits (internally and externally) through agenda management, scribe/note taking, and back-room assistance including material preparation
- Monitor the completion of key actions from audits, management reviews, or other Quality/Regulatory activities
- Prepare official quality and regulatory documents amp; communications such as SOPs, Declaration of Conformity, response to inquiry, and Technical Documentation Files
- Gather and report on key quality and regulatory metrics under the guidance of the management team
- Coordinate global department meetings amp; events occasionally.
Requirements
- Bachelor’s degree in quality, regulatory, engineering, science or other technical fields.
- 0-2 years of experience in quality or regulatory in a highly regulated environment
- Communication: Effective communication amp; technical writing skills. Fluent in English (spoken and written) is a must for the role alternate language fluency is a plus
- Analytical thinking Ability to draw relevant conclusions from data, manipulate data for presentation and reporting, identify patterns, and come up with viable solutions, all while adhering to deadlines
- Self-motivation This role is flexible and varies from day to day. It’s often up to the individual employee to determine what needs to be done. The successful candidate can identify solutions independently and work with minimal supervision
Benefits
- Career opportunities in a fast-growing company with worldwide reputation
- A flexible and friendly working environment with a collaborative atmosphere
- Fantastic office locations in Switzerland
- An exciting company mission that brings together science and technology to directly impact the lives of patients with life threatening illness.
- A fast-growing company with plenty of opportunity for personal growth and development
Start: ASAP (or as agreed)
Contract type: permanent full-time
Application process
If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.
After an initial screening process, candidates will be invited for remote interviews. Selected candidates will then be invited for personal interviews.