Senior Regulatory Affairs Specialist
SOPHiA GENETICS, France

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 amp; passion for healthcare toSOPHiA GENETICSas our new Senior Regulatory Affairs Specialist for Bidart in France.

Why us:

We believe there is a smarter, more data-driven way to make decisions in health. SOPHiA GENETICS (Nasdaq: SOPH), is a cloud-native software company and a leader in data-driven medicine. We are dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM Platform, a cloud-native platform, capable of analysing data and generating insights from complex multimodal data sets and different diagnostic modalities.

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.

Requirements

The value you add

• 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 amp; country-specific regulatory submissions
• supporting IVDR requirements such as EUDAMED reporting, post-marketing surveillance and promotional content review

The experience you bring

• Minimum 4 to 5 years' experience in Regulatory.
• 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.
• 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.
• As we pioneer within new and innovative spaces, an entrepreneurial and commercial mindset will see you best set for success.
• Demonstrated success in the preparation and completion of regulatory submissions.

Benefits

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

Business recognition and accolades include:

· World's most innovative companies (Top 10)

· World's smartest companies (Top 50)

· 100 Best Places to Work in Boston

· Top 10 European Tech Startup - 2020

· Top 10 European biotechs startup to watch - 2021

· Top 25 East-Coast Biotech to watch - 2021

Plus, you will find:

· A flexible, friendly, and international working environment with a collaborative atmosphere

· Flexible working hours, including hybrid remote / on-site working model

· 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

Location: Bidart (FR) - Office-based, including 2 days remote working per week.

Start: ASAP (or as agreed)

Contract type: Permanent in full-time

Application process

Apply now with your CV and any supporting information.

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 stakeholders from across the business.

All resumes should be in English for a successful review!

Job Rewards and Benefits