Senior Manager, Regulatory Affairs

Do you want to own 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 Manager, Regulatory Affairs.

Ideally you will be located within proximity to our Bidart office, but suitably qualified hybrid or remote candidates are encouraged. In line with EU AR / PRRC requirements, this individual should be located in France.

As an international organisation, our business language is English. CVs should be submitted in English for successful review.

Your mission:

Reporting to the VP, Quality & Regulatory, you will lead our global RA Team enabling us to drive forward with new and existing products within the global regulatory landscape. You will own and develop the strategies to ensure regulatory compliance.

What you'll achieve:

Develop, implement and execute regulatory strategies for selected projects and lead project management for product registration/submission for diagnostic and RUO, in international markets (EMEA, NORAM, APAC and LATAM).

Drive and position SOPHiA GENETICS as a leading influencer on new and upcoming regulations within IVD, MDR and most importantly Software as a Medical Device

To ensure that products and processes comply with the legislation of the markets where they are or wanted to be distributed by monitoring and assessing worldwide registrations, trends and hot topics that may impact the company across all portfolios and by implementing regulatory changes to maintain registrations and compliance (ISO 13485:2016, IVDD, MDR, IVDR, 21 CFR 809, etc.).

Lead our global RA Team (4 FTE)

Requirements

BSc, MSc or PhD within a relevant field (Biology, Genomics, Biotechnology or wider life sciences)

Previous management 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.

As we pioneer within new and innovative spaces, an entrepreneurial and commercial business-first 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 (Bidart) or Hybrid/Remote as agreed (FR)

Contract type: Permanent, Full-time