Робота Quality & Regulatory Affairs Manager в DataArt - Робота на dev.ua

Досвід роботи

Senior

Формат роботи

Remote

Вид зайнятості

Full time

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Деталі вакансії

Position overview

DataArt is a global software engineering firm. With over 25 years of experience, teams of highly-trained engineers around the world, deep industry sector knowledge, and ongoing technology research, we help clients create custom software that improves their operations and opens new markets. DataArt started out as a company of friends and has a special culture that distinguishes it from other IT outsourcers.

DataArt’s Healthcare & Life Sciences division is looking for a Quality & Regulatory Affairs Manager who wants to contribute to our further growth and maturity in the area of Software as a Medical Device (SaMD). If you are eager to push medical projects forward and bring regulatory-compliant apps to EU and US markets, we welcome you to our team.

As a Quality & Regulatory Affairs Manager you will work as our internal expert for regulatory and quality management topics in many Healthcare & Life Sciences projects with different approaches. You will get in touch with a lot of people in the industry and help them to combine regulatory affairs and agile software development.

Responsibilities

Drive establishment, certification and further development of DataArt’s Quality Management System in the area of Software as a Medical Device (SaMD)
Monitor and assess international Regulatory developments (e.g. FDA and EU guidelines) related to the company’s projects. Taking ownership in implementing new regulatory requirements in the Quality Management System, evaluate and improve it
Work closely with the management and project teams to ensure the delivery of regulatory compliant medical software products to our clients (including the creation and maintenance of the necessary regulatory documents)
Consult clients in all aspects of regulatory compliance related to SaMD
Collaboration with corporate functions (HR, IT, sales, etc.) in accordance with company’s QMS
Internal (DataArt teams) and external (DataArt clients) consultations in all aspects of medical device regulatory compliance
Drive preparations and passing through internal and external audits, communicate with external auditors

Requirements

Degree preferable in engineering, (medical) technology, life sciences or comparable qualifications
Understanding principles of Software Development Life Cycle (SDLC) and Agile methodology
Expertise in Software as a Medical Device (SaMD) and related regulations and guidance documents in US and Europe. For example, 21 CFR part 820 and related FDA guidance documents, Medical Device Regulation (MDR/IVDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, etc.
Fluent in English (German would an asset)

Nice to have

5+ years of experience working in the area of custom software development with US and/or EU companies
Structured way of thinking with accuracy and attention to details
High independence and hands-on mentality
Analytical thinking, strong analysis and documentation skills
Good team player and communication skills

Інформація про компанію

DataArt is a global software engineering firm that takes a uniquely human approach to solving problems. DataArt has earned the trust of some of the world’s leading brands and most discerning clients, including Nasdaq, Travelport, Ocado, Centrica/Hive, Paddy Power Betfair, IWG, Univision, Meetup and Apple Leisure Group among others.

Розмір компанії: 5001–10 000

https://www.dataart.team/

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Більше від DataArt

Middle Full time Remote

Position overview

DataArt’s SRE Center of Competence successfully develops and provides SRE expertise and solutions for our clients.

We are looking for a Senior SRE specialist who will join our team and provide consulting services to our clients and delivery teams.

The Senior SRE expert will participate in sales/pre-sales and discovery, provide consultancy and architecture reviews, and supervise projects during all the stages of development.

We offer an opportunity to grow professionally: lead initiatives, expand your SRE skills and technologies, mentor colleagues, and participate in R& Ds or PoCs.

Responsibilities

Collect and analyze data metrics, traces, and logs from the environment and the application
Take part in system design consulting, platform management, and capacity planning
Analyzing the requirements and supporting them from an SRE perspective
Assist in making decisions regarding the priorities of feature development and reliability improvements based on the current state of the system
Partner with development teams to improve services through rigorous testing and release procedures

Requirements

Programming skills with at least one of any modern programming language
Experience with containerized environments, Docker, Kubernetes
Experience managing code, database, infrastructure (networking, operating systems, storage)
Experience with monitoring frameworks (Grafana, Kibana, Prometheus)
Experience with IaaC and related tools (e.g. Terraform, CloudFormation)
Experience with modern CI/CD (e.g. Github Actions)
Experience with a major Cloud Provider (e.g. AWS, GCP, Azure)
SRE experience within a service development team for supporting, troubleshooting, and log analysis to meet our service availability and observability
Experience maintaining Service Level Objectives (SLO) / Service Level Indicators (SLI)
Good spoken and written English, great communication skills
Teamwork experience

Nice to have

Strong knowledge of a scripting language (e.g. Python, Bash)
Experience with OpenStack
Strong Linux or Windows system-level analysis capabilities
Experience optimizing cloud cost and reducing system resource usage by setting clear requirements through efficiency and capacity planning
Experience with varieties of SaaS operation tools like uptime, Dynatrace, PagerDuty
Experience in improving documentation on-site reliability measures, either in application documentation or in runbooks, explaining the issues encountered and the solutions implemented
Experience in a negotiation process within a team or during inter-team communication

Middle Full time Remote

Client

Our client creates AI-based technologies for the medical industry. One of their developments makes clinical research simpler.

Project overview

The challenge facing the company is to expand its web application for hospitals and research organizations. The project is based on Agile processes.We invite to the company, not a project

Team

The project team consists of up to 10 people.

Position overview

We’re looking for a Backend/Data Engineer who is hands-on build/test/manage data pipeline written in Scala.

Technology stack

Scala, Cats, Akka (Actors, Streams, HTTP), Slick, json4s, ScalaTest and ScalaCheck, Kubernetes, Postgres, ElasticSearch, Kafka.Responsibilities

Extending/Managing the pipeline implementation
Troubleshoot/fix issues on the pipeline services
Analyze and improve the performance of the pipeline
Participating in the full development life-cycle of a software product
Write clean code, take pride in your work, and value simplicity, testing, and productivity as part of your daily routine
Embrace new languages and frameworks, containers, and cloud
Explore the inner workings of the tools and libraries you use to understand how they work

Requirements

3+ years of software development experience
At least 1 year of experience with Scala library Cats
Good experience and deep understanding of Scala programming language
Experience with testing frameworks such as ScalaTest and ScalaCheck
Must have experience with Scala libraries such as Akka (Actor, Streaming, HTTP, Alphaka, Kafka), Slick, json4s
SOLID and software development best practices knowledge
Experience with Agile methodologies
Good spoken English

Nice to have

Nice to have working experience in Kubernetes, Postgres, ElasticSearch, Kafka

Senior Full time Remote

Client

Our client is a European investment firm and solutions provider, focusing on private debt and opportunistic credit investments.

Project overview

We, as the client’s technology partner, are starting a program to redesign and modernize the system. It will complete the re-development of the existing business logic on modern technology in the cloud.

It’s a new project, so you will have an opportunity to suggest technologies and the best solutions.

We invite to the company, not a project

Team

DataArt’s specialists work with the client’s in-house team and we are planning to grow our team to 10+ people.

The team follows the Scrum process and requires tight collaboration with the in-house product and development teams located in UK and Europe.

Position overview

We are seeking an experienced and mature Ruby Developer to join our project team.

Technology stack

Ruby, Vue.js, Python, AWS.Responsibilities

Design, build, and maintain efficient, reusable, and reliable Ruby code
Ensure the best possible performance, quality, and responsiveness of the applications
Identify bottlenecks and bugs, and devise solutions to these problems
Help maintain code quality, organization, and automatization

Requirements

3+ years of Ruby development experience
Experience of integration with 3rd party systems and services
Experience in deploying Rails applications
Experience working with relational databases
Spoken English

Nice to have

Experience with JS (Vue preferably) will be an advantage

Усі вакансії компанії