Compliance Manager
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.
Your Client
Our Client is one of the leading manufacturers of hearing aid devices. Capgemini Engineering acts as an R&D partner with wide ownership in both technology and documentation (compliance). Our products are mobile apps mostly intended to communicate and remotely control hearing devices and their accessories via Bluetooth. The apps are integrated into a bigger ecosystem that includes cloud services and web solutions.Currently we are looking for a Compliance Manager to join the team of professionals. New member of a team will ensure that project processes are in compliance with Clients IMS and regulation (ISO 13485 and IEC 62304) and continuously improve project processes.
Your Role
- Guides personnel how to comply with rules and processes
- Organizes retrospective meetings to improve processes
- Manages client-provided assets and conducts inventory
- Coordinates risk management activities
- Interacts with the Client's quality manager on regulatory issues
- Coordinates the review and management of documentation created in accordance with regulatory requirements and the Client's QMS (standard operating procedures, templates)
- Participates in internal and external audits
Your Profile
- 1+ years of experience in a combination of compliance, QMS, risk management
- Practice-based knowledge of frameworks such as ISO 9001, ISO 13485, IEC 62304 or equivalent standards
- Experience in using documentation and issue tracking tools (SharePoint, Jira, Confluence, etc.)
- Solid understanding of a software development lifecycle
Nice to have
- Risk management experience according to ISO 14971:2019 standard
- Cybersecurity risk management experience
- Knowledge of performing privacy impact assessment-related activities
What You Will Love About Working Here
- We care about all our employees and want them to feel as comfortable as possible. That's why we offer them health insurance from the first days, regardless of the probationary period.
- The gift from the company - Christmas holidays from 25 December to 31 December.
- Сooperation with Superhumans center and Veteran HUB. Capgemini Engineering has supported the launch of psychological rehabilitation department of Superhumans. Our team also donated over UAH 500 000 prosthetics for three Ukrainian defenders. Currently, we support psychological counseling provided by the Veteran Hub, and we have implemented an internal policy making the company friendly to military and veterans with the assistance of the Hub.
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
Kyiv, UA