Quality and Information Security Compliance Manager

August 11

Apply Now

Receive Emails with Similar Jobs

Smart Reporting GmbH

WebsiteLinkedInAll Job Openings

Start-up • Digital Medicine • eHealth • Artificial Intelligence • Healthcare

51 - 200

Description

• Act as Quality Management Representative, overseeing QMS document control, creation, revision, and approval • Manage CAPA processes, ensuring nonconformities are identified and addressed • Organize and manage internal and external audits • Provide QMS training and support to employees • Conduct management reviews, presenting QMS compliance and effectiveness • Guide teams on QMS processes • Create and review technical documentation per EU 2017/745, non-EU country regulations, US FDA 21 CFR and medical device regulations of other regions • Conduct risk management for Smart Reporting products according to ISO 14971 • Act as Information Security Compliance Manager, ensuring compliance with various standards • Take ownership of our Information Security Management System, keeping documentation, guidelines, and SOPs up to date • Deliver management reports and annual security submissions • Track risk management and InfoSec changes according to ISO27001 • Coordinate InfoSec and GDPR trainings, and manage supplier evaluations

Requirements

• You have profound experience in Quality Management for Medical Devices and you have contributed or lead building/maintaining a QMS, and have actively participated in internal and external audits • Familiarity with ISO 13485, European Medical Device Regulation, ISO 14971, norms like ISO 62304, ISO 62366, corresponding guidance documents and their application • You are confident to find the right balance between building an audited QMS for Software as a Medical Device while keeping it lean for swift and agile operations • You feel comfortable with the coordination of processes and guiding your colleagues in the application of the QMS and ISMS • You have a basic understanding of common technical and organisational measures relating to information security. You are familiar with the requirements of ISO27001 and feel comfortable acting as the internal compliance manager (You will be responsible for the coordination of InfoSec compliance - related tasks but will be able to rely heavily on external experts for detailed knowledge) • You are business fluent in German and English and you have strong overall communication skills

Benefits

• The opportunity to contribute to a cutting-edge medical software product with rapid growth and significant funding from top-tier investors and EU grants • Working for a meaningful product that positively impacts healthcare and people's lives • Joining a positive, highly skilled, and international team • LinkedIn Learning licenses and individual development budget to support your professional growth • Regular Company Events, Jobticket, Jobrad, and further Benefits • Part-time eligible, flexible working hours and up to 100% Remote work possible • Competitive compensation • 30 days paid vacation