Compliance Manager for Lohika Project

13 апреля


Технологии:
compliance manager ism iso communication education qms sharepoint jira confluence solid risk cybersecurity
Английский: eng: Не важно

Purpose of the job:

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:

MUST HAVE:

  • 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
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