Quality Management – Regulatory Affairs Manager

Unora

. Maintain and continuously improve the quality management system in accordance with ISO 13485, the MDR, and MDSAP .

Posted 10/19/2026full-timeBerlin • GermanyMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in maintaining quality management systems in compliance with ISO 13485, MDR, and MDSAP, while effectively managing CAPA activities and conducting audits. Proficient in preparing technical documentation and engaging with regulatory authorities to ensure market authorization of medical devices.

Highest-signal resume keywords

ISO 13485 ComplianceRegulatory Affairs ExpertiseInternal Auditing ExperienceTechnical Documentation PreparationBilingual Proficiency in German and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System (QMS)Risk Management ProcessesCAPA ManagementSupplier AuditingRegulatory AssessmentsInternal and External AuditsTechnical DocumentationMarket Authorization ProcessesRegulatory Trends MonitoringChange Control Process

Soft Skills

Strategic CapabilitiesExecution-Focused ApproachCommunication Skills

Tools & Technologies

QMS SoftwareDocument Control SystemsAudit ToolsRegulatory DatabasesEUDAMED

Certifications & Qualifications

Auditor Qualification

Industry Keywords

Medical DevicesMDR (EU 2017/745)MDSAPClinical DocumentationPMCF ActivitiesNotified BodiesRegulatory Authorities

About the role

Key responsibilities & impact

Maintain and continuously improve the quality management system in accordance with ISO 13485, the MDR, and MDSAP
Promote awareness of quality-related requirements throughout the organization
Conduct management reviews and training sessions
Monitor system effectiveness and manage CAPA activities
Apply and oversee risk management processes
Qualify and monitor suppliers, including audits, and conduct regulatory assessments of supplier changes
Act as deputy for the Clinical Affairs Manager in clinical documentation and PMCF activities
Report on quality matters to management and regulatory authorities
Plan and conduct internal and external audits in accordance with ISO 13485, the MDR, and MDSAP
Manage CAPAs and deviations within the team and in collaboration with relevant departments
Systematically monitor production and quality assurance processes
Ensure the conformity and market authorization of medical devices in the EU, Switzerland, the UK, and international markets
Prepare, maintain, and update technical documentation, including UDI data, EUDAMED entries, and labeling
Conduct regulatory assessments of changes within the change control process
Monitor regulatory trends and derive necessary actions
Provide regulatory approval for labels, IFUs, and claims

Requirements

What you’ll need

Completed degree or vocational training in engineering, natural sciences, or medicine, along with several years of professional experience in quality management and regulatory affairs for medical devices
In-depth knowledge of ISO 13485, the MDR (EU 2017/745), and, where applicable, MDSAP requirements
Experience as an internal auditor; auditor qualification is preferred
Experience preparing and maintaining technical documentation
Strong strategic capabilities combined with a hands-on, execution-focused approach
Excellent written and spoken German and English
Proficiency in QMS software, document control systems, audit tools, and regulatory databases such as EUDAMED
Experience working with regulatory authorities, Notified Bodies, and customers

Benefits

Comp & perks

Meaningful work – Your work helps ensure that life-sustaining medical devices can be manufactured and used reliably
Great team: A motivated and supportive environment that has your back
Company pension plan with a 20% employer contribution for a secure future
Individual professional development opportunities to support your professional and personal growth
Business bike leasing for environmentally friendly and healthy mobility
Mobility or sports allowance: Choose between a subsidy for a BVG public transport pass or Urban Sports Club