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Stellenquelle: headcount AG, , Switzerland
CHF 125.000 - 150.000
Would you like to be part of a dynamic and exciting team delivering high level support that has a direct impact on the lives of cancer and rare disease patients worldwide? Do you want to own the regulatory lifecycle of SOPHiA GENETICS product as we pioneer within healthcare?
Bring your knowledge and passion to SOPHiA GENETICS as our new Regulatory Affairs Director.
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 pre-market and post-market regulatory compliance.
Responsibilities:
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
Your background:
Previous management/leadership experience within the regulatory affairs function of an IVD 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.
BSc, MSc or PhD within a relevant field (Biology, Genomics, Biotechnology or wider life sciences)
As we pioneer within new and innovative spaces, an entrepreneurial and commercial business-first mindset will see you best set for success.
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 Lead Talent Acquisition Partner
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 (3 Days PW) - Rolle
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