SOPHiA GENETICS

Regulatory Affairs Assistant, Lausanne - Switzerland

We are looking for a smart and passionate Regulatory Affairs Assistant with at least 2 years of experience in the medical device industry.

The Regulatory Affairs Assistant will report directly to the Regulatory Affairs Manager and will be responsible for supporting the regulatory activities related to product registration, product maintenance and regulatory research for new product development and existing activities follow-up, ensuring compliance with applicable statutory requirements.

Responsibilities

  • Compile required documents from product submissions, license renewals, annual registrations and maintenance of product registration dossiers for authorities. This include the research of regulatory requirements per country of registration, the monitoring of existing registrations for renewal dates and the update of dossiers/technical documentations.
  • Ensure that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local/regional regulatory requirements, commitments and agreements.
  • Maintain database with information on regulatory requirements per country and on registration status of product portfolio.
  • Work closely with and supports Regulatory Affairs Manager in daily tasks and projects.
  • Ensure that the content, organization and overall quality of all regulatory documents and samples are adequate and complies with local/regional regulatory requirements, commitments and agreements.
  • Support the insurance of compliance of SOPHiA GENETICS products with the current regulations across the countries.

Qualifications

  • Master’s degree in life sciences (genetic, molecular biology or bioinformatic preferred).
  • Minimum of 2 years of post-academic professional experience in QA or RA in the medical device industry.
  • Knowledge, understanding and experience in MD/IVD regulations such as MDD/MDR, IVDD/IVDR, FDA regulations, etc.
  • Knowledge and experience in ISO 13485.
  • Experience with software development is a plus.
  • Strong interest in genomics and radiomics
  • Ability to work independently with self-discipline skills.
  • Ability to work under stress to meet deadlines in a multitasking environment.
  • Ability to take initiatives, be proactive and have good follow-up skills
  • Excellent prioritization and time management skills.
  • Effective administration skills, good planning and organizing skills.
  • Must use initiative, be proactive and have good follow-up skills.
  • Strong interpersonal and communication skills.
  • Excellent written and oral communication skills
  • Results oriented, strong attention to detail, problem-solving and analytical skills.
  • Full professional proficiency in English and French.
  • Valid permit to work in Switzerland.

Starting date: As soon as possible

Location: St-Sulpice (VD), Switzerland

If you are an energetic and dynamic regulatory talent and you want to support a variety of medtech-related regulatory matters, all in a fast-paced work environment, we’d be keen to hear from you.

Please note that incomplete applications will not be considered.