Senior Compliance Manager – Quality & Regulatory Affairs, QMS Representative (QMB), ISO 13485

Vivira Health Lab

. Own and manage Vivira’s quality management system .

Posted 10/23/2026full-timeBerlin • GermanySeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing quality management systems in the medical device industry, with a strong focus on compliance with ISO 13485, MDR, and DiGAV. Proficient in developing processes, conducting audits, and maintaining technical documentation while ensuring effective collaboration across departments.

Highest-signal resume keywords

Quality Management System OwnershipISO 13485 ComplianceMDR Technical DocumentationInternal Audits PlanningRegulatory Compliance Monitoring

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality ManagementISO 13485MDRDiGAVRisk-Based SolutionsTechnical DocumentationPost-Market SurveillanceAudit PreparationRegulatory Changes EvaluationSoftware Supplier Assessment

Soft Skills

Detail-OrientedProactive CollaborationIndependent Working Style

Tools & Technologies

ConfluenceJiraMatrix RequirementsAtlassianHubSpotGoogle

Industry Keywords

Medical Device IndustryDigital HealthSaMDBSI CertificationISO 27001

About the role

Key responsibilities & impact

Own and manage Vivira’s quality management system
Serve as Quality Management Representative (QMB) under ISO 13485
Report directly to the Team Lead, Compliance, and collaborate closely with Engineering and Product
Monitor compliance with DiGAV, MDR, ISO 13485, and ISO 27001
Contribute to BSI certification activities
Develop and improve processes, SOPs, and work instructions in a pragmatic, risk-based manner
Create and maintain MDR technical documentation (DHF/DMR) for three medical devices
Prepare for and follow up on external audits with the certification body
Plan and conduct internal audits
Prepare for the ISO 13485 recertification audit in February 2027
Review and approve release documentation
Manage post-market surveillance for Vivira products
Assess and monitor software suppliers such as Atlassian, HubSpot, and Google based on their criticality
Evaluate regulatory changes monthly and derive concrete actions
Act as the primary contact for regulatory questions across departments
Train colleagues and proactively obtain required contributions
Potentially take on the PRRC function, depending on qualifications and agreed responsibilities

Requirements

What you’ll need

At least three years of relevant experience in the medical device industry
Practical knowledge of the MDR and ISO 13485
Experience preparing for, participating in, and following up on audits
Willingness to take on the QMB role in accordance with ISO 13485
Technical understanding of software development, including frontend/backend, releases, and tickets; programming skills are not required
A background in hardware or implants is welcome
Structured, detail-oriented, and independent working style
Proactive collaboration and follow-up with colleagues
Ability to develop pragmatic, risk-based solutions
Very good German skills, at least C1 level
Very good English skills
Experience with DiGA or Digital Health, SaMD, ISO 27001/ISMS, or BSI certifications is advantageous but not required
Knowledge of Confluence, Jira, or Matrix Requirements is advantageous but not required

Benefits

Comp & perks

Hybrid work in Berlin, with 1–2 days per week in the office
Work from the EU, EEA, Switzerland, Israel, or the UK for up to one month per year
30 vacation days
Vivira app for personal back health
Enhanced employer contribution to occupational pension
Corporate benefits for shopping, technology, and more
Referral bonus for successful referrals
Several company and team events per year
Professional development opportunities in a growing international team
Ownership, autonomy, and short decision-making paths