Regulatory Affairs Associate
vor 4 Wochen
**_We believe there is a smarter, more data-driven way to make decisions in health_**. **As we pass 1,000,000 genomic profiles analyzed and look to the future of our platform, we are now searching for a Project Manager who will be help in transitioning our platform to the next level
Our mission is to bring data analytics solutions to market, to support healthcare professionals by maximizing the power of Data-Driven Medicine. SOPHiA GENETICS (NASDAQ: SOPH) combines collective intelligence in Genomics, Radiomics, clinical research data, the DDM -Data-Driven Medicine,we can ensure that the data used to help patients today will also benefit the patients of tomorrow.
We observed that across the healthcare ecosystem, a vast amount of digital healthcare data is being generated, fuelled by technologies such as next-generation sequencing ("NGS"). This data holds promise to accelerate our understanding of biology and disease.
Be part of our mission to disrupt healthcare and democratize data driven medicine SOPHiA GENETICS is looking for a **Regulatory Affairs Intern** to join the Regulatory Affairs team based in **Rolle**.
The Regulatory Affairs Intern will work closely with the Regulatory Affairs team to support regulatory projects and to participate to the analysis of customer complaints (updating risk management, instructions for use, initiate change controls). The internship has **three** main goals:
**Responsabilities**:
**Vigilance / Complaint Support **:Work closely with the Regulatory Affairs vigilance and complaint handling champion by daily monitoring and evaluating of customer complaints as required by post-market surveillance obligations for marketed products.
- Monitor the customer complaints that are reported to regulatory affairs.
- Evaluate, with the assistance of experts, if the event is directly related to a CE-IVD product.
- Contribute to mitigation actions to address risks identified via the complaints.
- Write a summary of selected complaints that were assessed by the regulatory colleagues.
**Labelling Support **:Work closely with the labelling champion to assist in the management and creation of technical labels.
- Compile label content for the generation of labels via the ROBAR label management system
- Assist in the creation of label packets
**Support in the review of Promotional Material **:Work closely with the Compliance team to ensure promotional compliance.
- Collaborate with the Marketing team to evaluate promotional materials and actively suggest changes to allow compliant asset to be used externally
- Provide guidance and trainings to new comers on promotional compliance
You will also have the chance to be involved in **other Regulatory affairs tasks** including:
- Identifying international registration requirements
- Preparing regulatory presentations to explain how newly published requirements (e.g. standards or guidances) impact the SOPHiA GENETICS activities.
**Requirements**:
- Have or enrolled in Bachelor or Master Degree program Life Science (preferably a biomedical field)
- Exposure to medical devices or in vitro diagnostics regulation is desirable
- Fluent in English is a must. Fluent in French is a plus.
- Excellent communication and interpersonal skills
- Excellent team player & self-driven
- Excellent attention to details
- Capacity to prioritize, well-organized and able to multitask
- Desire to discover or deepen knowledge of IVD regulations
**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**: Rolle, Switzerland. Office-based, including 2 days per week remote / 3 days on-site.
**Start**: ASAP (or as agreed)
**Contract type**: Internship - 6 months duration (_possible to negotiate reduced hours to align with study obligations after the summer if part of contract)._
**Application process**:
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