You are looking for a position where to share your knowledge in regulatory and quality topics in the Tech and biopharma industry with an international scope. Bring your knowledge amp; passion for healthcare to SOPHiA GENETICS as our new Regulatory Affairs Associate 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.
Requirements
Your mission:
As a Regulatory Affairs Associate, your goal is to register products into various market and constantly monitor and update regulatory documentation as necessary to keep company in compliance from a regulatory perspective.
The value you add
- Fluent in English by working in an international environment, you have more than 3 years’ experience in regulatory and quality affairs for medical device or In-Vitro Diagnostic company.
- Team-worker, flexible and collaborative mindset to be able to work with your colleague, across departments and develop new market strategies that meet revenue and growth forecasts.
- Able to handle multiple competing tasks with great attention to detail and to work independently to achieve objectives on or before schedule.
- Excellent written and verbal communication skills including communicating complex scientific topics in simple terms to internal and external partners.
The experience you bring
- Comprehensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.
- Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and IVD directive IVDD 98/79/EC.
- Knowledge of EU MDR and IVDR.
- Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure.
- Demonstrated success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE) to FDA and/or other global regulatory agencies.
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