Be part of our mission to disrupt the healthcare and democratize the data driven medicine! SOPHiA GENETICS is looking for a Technical Documentation Specialist to join our Regulatory Affaires team in Rolle, Switzerland.
As a Technical Documentation Specialist you are the product technical expert who ensures all customer-facing technical documentation including labels and responses to customer technical inquiries or complaints are accurate, compliant, professional and timely.
You are an expert in next generation sequencing workflow based on at least 2 years of practical bench level experience.
Responsible for creating, maintaining and obsoleting customer-facing technical documentation including User Guides, protocols, labels, and IFUs
Ensures documentation is compliant with regulatory requirements
Specializes in creating clear and user-friendly documentation
Supports regulatory submissions as needed
On-Market Technical Product Support
Provides on-market support by helping create technical templates for Level 1 & 2 customer answers and reviewing Level 3 tickets as needed
Supports technical product training of SMEs, and collaborates closely with Knowledge Manager to develop effective technical training programs through shared materials
Act as Cross Departmental Partner for Efficient Troubleshooting
Closely collaborates with technical teams / R&D to efficiently troubleshoot customer issues related to labeling
Practical hands-on Next Generation Sequencing Experience is an absolute minimum requirement
Masters or higher degree in life science
3+ years of relevant experience, in the life science or diagnostics field
Fluent in spoken and written English is a must
Technical writing experience
Excellent organizational skills to define timelines, set priorities and deliver on time
Excellent written and verbal communication skills including communicating complex scientific topics in simple terms to internal and external partners.
Familiarity with IVDR, FDA CFR, and / or ISO 18113 labeling standards a plus
A flexible, friendly and international working environment with a collaborative atmosphere
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
A hard technical challenge to solve with exciting modern technology - cloud computing, Big Data, DevOps, machine learning
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.