Business Analyst for a HealthCare project

Вакансії
PLWarsawGrzybowska 6000-844

Summary

Hot vacancy!

We are extending our BA HealthCare Team!

Don't miss the opportunity to work with domain professionals.

Andersen, an international IT сompany, invites a HealthCare Compliance Consultant / Healthcare Business Analyst to work on a large-scale project for one of our German customers.

The project is providing clinics with devices, equipment, and software that will help in the aftercare treatment and creation of personalized rehabilitation for patients with neurological conditions.

The customer is a medical device company from Germany, that develops therapy software for people with neurological diseases, combining neuroscience, gamification and virtual reality.

Responsibilities:

  • Participating in Discovery phase (approximately 5 weeks), then supporting the team during development phase;
  • Consulting colleagues on compliance of certain product development requirements with current regulatory requirements;
  • Analyzing and specifying requirements during the development process;
  • Keeping up to date project specifications for knowledge sharing between project teams and requirements reuse;
  • Closely working with project teams and technical specialists to ensure successful project delivery;
  • Preparing an audit report for a Healthcare medical device VR project.

Requirement to Audit Report:

Audit report shall define what should be done in part of deliverables to meet defined classification of the Product and related standard requirements.

The audit report should be presented as a check-list of what is required from the certification part, what is out of scope and explanations, and what should be done from the Project part. Audit report should consist of the list of deliverables that should be transferred to Customer. Also the Audit report should consist of the required set of training.

Requirements

  • Experience as a HealthCare Compliance Consultant / Business Analyst for 3+ years;
  • Experience with systems involving interaction with patients, their data, etc.;
  • Experience of developing regulatory documentation and business process analysis;
  • Applicable standards for development SaMD (basically ISO 13485:2016);
  • Knowledge of HL7, FHIR and DICOM protocols;
  • Level of English - Upper-Intermediate.

Desired skills

  • Participation in the Discovery phases;
  • Experience in medical device integration projects;
  • Education and work experience in medicine;
  • Applicable standards for development SaMD:
  • Knowledge of HL7, FHIR and DICOM protocols.

ISO 13485:2016 Medical devices (Quality management systems — Requirements for regulatory purposes);

ISO 27001 Information security management (Information security management system — Requirements for financial information,

intellectual property, employee details or information entrusted by third parties);

ISO 14971:2019 Risk management (Application of risk management to medical devices);

IEC 62304:2006/AMD 1:2015 - Medical device software (Software life cycle processes);

IEC 62366-1:2015 - Usability requirements (Application of usability engineering to medical devices);

IEC 82304-1:2016 - Health software (General requirements for product safety);

Reasons to join us

  • At Andersen, you will enhance your CV by working on projects for such global brands as Samsung, Johnson & Johnson, Ryanair, Europcar, and many others. Our company never runs out of good projects, so you won’t stay on the sidelines;
  • We have been strengthening our expertise since 2007. During this time, we have formed an excellent BA & SA team with streamlined processes, which now consists of more than 200 qualified analysts;
  • Our employees work from anywhere in the world: at the company's offices or from home, and even combine both formats in the way that suits them best. Coworking with compensation is also possible;
  • You will have a stable competitive EUR-pegged salary and enjoy an extensive benefit package. Also, if you want to, you will be able to increase your income by taking on additional activities;
  • We give our employees an opportunity to attend and participate in the company’s BA meetups, as well as offer a compensation program for international professional certificates;
  • Your career will be in your hands! We offer a clear assessment system and draw a roadmap to your goals. Develop as a specialist or manager, and your achievements will be appreciated at their true value and rewarded.
  • You will have an opportunity to take on the role of a mentor and help a group of BA/SA beginners grow;
  • Our employees have access to Andersen Knowledge Base, where they can take courses in a variety of areas: the art of negotiation, PreSale & Discovery, Agile essentials, product ownership, microservice architecture, API design, SQL, AWS, GDPR, UX/UI, people management, and more.

Join us!

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