Intern - Regulatory Affairs

☞ SOPHiA GENETICS

View: 116

Update day: 25-04-2024

Location: Lausanne Vaud VD

Category: Legal / Contracts Internship / Entry level

Industry: Biotechnology Research

Position: Internship

Job type: Internship

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Job content

Description

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 Saint-Sulpice.

The Regulatory Affairs Intern will work closely with the Regulatory Affairs team to support the regulatory project and to participate to the analysis of customer complaints (updating risk management, instructions for use, initiate change controls). The internship has two main goals:
  • Regulatory Affairs support

Work closely with the Regulatory Affairs associates to assist in the organization, compilation, and submission of documents required for regulatory compliance throughout the lifecycle of the products.
  • 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.

Your tasks for the first goal:
  • Contribute to the development and drafting of product specific regulatory strategies for products with assistance from regulatory colleagues.
  • Contribute to write, edit, and review administrative and technical documentation to achieve regulatory approval in the required market country.
  • Prepare regulatory presentations to explain how newly published requirements (e.g. standards or guidances) impact the SOPHiA GENETICS activities.

Your tasks for the second goal:
  • 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.

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

Start: ASAP (or as agreed)

Contract type: 6 months internship, full-time

(possible to negotiate reduced hours to align with study obligations after the summer if part of contract).

Location: Saint-Sulpice, Switzerland - Mandatory on-site

Application process:

If you think you fit this position, please send a CV and a cover letter. Please note that incomplete applications will not be considered.

After an initial screening process, candidates will be invited for remote interviews. Selected candidates will then be invited for personal interviews.
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Deadline: 09-06-2024

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