Senior Regulatory Affairs Specialist

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.

Your mission:

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
• supporting IVDR requirements such as EUDAMED reporting, post-marketing surveillance and promotional content review

Requirements

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 exclusively within pharma products is 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.

Benefits

You will be joining an organization with the patient at the heart of every decision and action, driven by purpose as we drive exponential growth.

The Process:

Apply now with your CV and any supporting information. For further information, contact our Senior Talent Acquisition Lead for Critical Hiring.

Suitably qualified candidates will be invited through an interview and screening process where you will speak with members of our Talent Acquisition Team, the hiring leader alongside key colleagues and stakeholder from across the business.

Starting date: ASAP as agreed

Location: Office Hybrid (CH/FR) or Home Office (EU5/CH)

Contract type: Permanent, Full-time