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About the Role

Vivira offers a digital movement therapy app for back pain, reimbursed by health insurance. As Senior Compliance Manager, you will be responsible for the Quality Management Representative (QMB) role according to ISO 13485, ensuring MDR compliance for medical devices, from audits to new product inclusions in the DiGA directory.

Responsibilities

Oversee the quality management system and act as the Quality Management Representative (QMB) according to ISO 13485.
Monitor compliance with DiGAV, MDR, ISO 13485, and ISO 27001.
Participate in BSI certification processes.
Develop processes, SOPs, and work instructions pragmatically and risk-based.
Create and maintain Technical Documentation according to MDR (DHF/DMR) for three medical products.
Prepare for and follow up on external audits with the certification body.
Plan and conduct internal audits.
Review and approve release documentation.
Be responsible for post-market surveillance of products.
Evaluate and monitor software suppliers based on criticality.
Analyze regulatory changes monthly and derive concrete actions.
Serve as the primary contact for regulatory questions across all departments.
Train colleagues on regulatory matters.
Actively solicit input from colleagues.

Requirements

Minimum of three years of relevant experience in the medical device field.
Practical knowledge of MDR and ISO 13485.
Experience in preparing, accompanying, and following up on audits.
Strong technical understanding of software development (frontend vs. backend, releases, tickets).
Structured, meticulous, and independent work style.
Proactive approach to colleagues and follow-up on required input.
Ability to state objections while proposing pragmatic, risk-based solutions.
Very good German language skills (minimum C1).
Very good English language skills.

Skills

Quality Management Systems (QMS)
Regulatory Affairs (RA)
ISO 13485
MDR (Medical Device Regulation)
DiGAV (Digital Health Applications Ordinance)
ISO 27001
BSI Certification
Technical Documentation
Auditing (Internal and External)
Post-Market Surveillance
Supplier Management
Risk Management
Process Development
SOP Development
Work Instruction Development
Confluence
Jira
Matrix Requirements

Location

Berlin (Hybrid)

Work Type

Hybrid
Working Abroad (up to 1 month/year from EU, EWR, Switzerland, Israel, or UK)

Experience Level

Senior

Benefits

Ownership and autonomy in shaping the QMS.
Broad scope of responsibilities including MDR, DiGA, ISO 13485, ISO 27001, and BSI.
Established system with planned handover.
Hybrid work model with 1-2 days in the office per week.
Opportunity to work abroad for up to one month per year.
30 vacation days.
Access to the company's back health app.
Increased employer contribution to company pension plan.
Corporate benefits for shopping, technology, and more.
Referral bonus.
Multiple company and team events per year.
Engaged team environment.

About the Company

Vivira offers a digital movement therapy app for back pain, reimbursed by health insurance.
Vivira Health Lab focuses on digital healthcare with added value.
The app is permanently listed as a DiGA (Digital Health Application) in the BfArM's reimbursement directory.
Vivira is an international, growing team based in Berlin.
The company aims to shape digital medicine in a human, innovative, and collaborative way.
Vivira's culture is based on responsibility, drive, and friendliness.
The company fosters initiative, diversity, and collaboration.
Employees can develop professionally, implement exciting projects, and directly improve people's quality of life.