Do you want to navigate the regulatory life cycle of SOPHiA GENETICS products, as we pioneer into newly discovered fields and combine complex, multi-modal data into our fully integrated SaaS platform? Are you innovative and passionate to be a proactive influencer on regulatory authorities?
Bring your knowledge and passion to SOPHiA GENETICS as our new Senior Regulatory Affairs Specialist.
Enjoy collaborating with colleagues internationally with our hybrid work arrangement, either connected to our offices in France (Biarritz) and Switzerland (Geneva) or remotely from a EU5 country.
As part of the global regulatory team, you will enable us to drive forward with new and existing products within a regulatory landscape.
What you'll achieve
- Be responsible for the organisation, compilation and submission of global product applications, whilst supervising ongoing regulatory activities throughout the lifecycle
- Have an active awareness of regulatory updates, with a mindful focus on where SOPHiA GENETICS can play the role of thought leader and influencer on new legislation.
- Carry out the strategic approach for global, regional & country-specific regulatory submissions
- BSc, MSc or PhD within a relevant field (Biology, Genomics, Biotechnology or wider life sciences)
- Previous experience within the regulatory affairs function of an In Vitro Diagnostics company is essential. Further exposure to software as a medical device or similar diagnostics software is valuable. Regulatory affairs experience for pharmaceutical products is less relevant and unsuitable.
- Working knowledge of global regulatory requirements including EU IVDD, IVDR, MDR and ISO 13485/14971. Knowledge of FDA QSR/ 21CFR Part 820 is advantageous.
- Direct exposure to creating and compiling regulatory submissions on an international/global basis. (EU Minimum, Inc US preferred)
- As we pioneer within new and innovative spaces, an entrepreneurial and commercial mindset will see you best set for success.