Our Client is one of the leading manufacturers of hearing aid devices. Lohika 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 Lohika ISM and regulation (ISO 13485 and IEC 62304) and continuously improve project processes.
MAIN TASKS AND RESPONSIBILITIES:
Guides personnel how to comply with rules and processes
Coordinates risk management activities
Communication with the client Quality Manager on regulation-related questions
Coordinate the review and management of documentation created according to the regulatory requirements
EDUCATION, SKILLS AND EXPERIENCE:
1 years of experience in a combination of compliance, QMS, risk management
Practice-based knowledge of frameworks such as ISO 9001, ISO 13485, or equivalent standards
Experience in using documentation and issue tracking tools (SharePoint, Jira, Confluence, etc.)
Solid understanding of a software development lifecycle
WOULD BE A PLUS:
Risk management experience according to ISO 14971:2019 standard
Cybersecurity risk management experience
Knowledge of performing privacy impact assessment-related activities