Head of Quality Management, Regulatory Affairs

epias GmbH

Quality Manager at epias GmbH enhancing ISO 13485 and regulatory affairs with innovative workflows. Collaborating on audits and maintaining medical documentation systems.

Posted 7/23/2026full-timeIdstein • 🇩🇪 GermanyLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality management systems, particularly in compliance with DIN EN ISO 13485 and DIN EN ISO 27001, while effectively integrating AI into quality and documentation processes. Proficient in conducting internal audits and maintaining regulatory documentation for medical devices.

Highest-signal resume keywords

Quality Management System DevelopmentDIN EN ISO 13485 ComplianceDIN EN ISO 27001 CertificationInternal Audits ExecutionRegulatory Documentation Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ManagementRegulatory ComplianceInternal AuditingTechnical DocumentationWorkflow DevelopmentAI IntegrationRisk ManagementData MonitoringClinical EvaluationPost-Market Clinical Follow-Up

Soft Skills

Training DeliveryCollaborationCommunication

Tools & Technologies

JiraGitHub

Certifications & Qualifications

Quality Management RepresentativeQM AuditorQuality ManagerInternal Auditor Certificate

Industry Keywords

MDR (EU 2017/745)Medical Device LegislationPeriodic Safety Update Report (PSUR)Management ReviewCorrective Actions

Tech Stack

Tools & technologies

TypeScript

About the role

Key responsibilities & impact

Responsibility for the further development of our quality management system according to DIN EN ISO 13485
Introduction and support of certification to DIN EN ISO 27001
Planning, monitoring, control and improvement of the quality management system across all departments
Support in maintaining and updating the technical documentation of our medical device
Development of intelligent workflows for creating, maintaining and reviewing regulatory documentation
Building an AI-supported management system with Jira and GitHub as central versioning and process platforms
Integration of AI into quality, risk and documentation processes
Preparation and execution of internal audits, including tracking of corrective actions
Conducting quality management training for employees
Monitoring and implementation of regulatory requirements in collaboration with our Responsible Person
Preparation and support for the annual MDR surveillance audits and recertifications by the notified body
Maintaining and further developing our documentation system in consultation with management
Regular preparation of the Periodic Safety Update Report (PSUR), the clinical evaluation, and the Post-Market Clinical Follow-Up (PMCF) report, including monitoring of required data, and preparing and supporting management for the annual management review

Requirements

What you’ll need

Degree in (Medical) Informatics, Biomedical Engineering, Electrical Engineering or a comparable medical or scientific-technical qualification
Certified training in quality management (e.g., Quality Management Representative (QMR/QMB), QM auditor or Quality Manager)
Knowledge of the MDR (EU 2017/745) and national medical device legislation
Knowledge of DIN EN ISO 13485 and 27001
Experience with Jira and GitHub is an advantage
Practical experience conducting internal audits, ideally with an internal auditor certificate

Benefits

Comp & perks

Permanent employment (part-time or full-time)
A collegial and supportive team working toward shared goals
Competitive salary
Flexible working hours and option for remote work
Individual training and development opportunities
Wellpass fitness membership
Bike leasing
30 days of annual leave per year
Company-wide shutdown on December 24 and December 31