Qbtech

Senior Quality & Regulatory Specialist – Transform ADHD Care

Qbtech

full-time

Posted on:

Location Type: Hybrid

Location: Stockholm • Sweden

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Job Level

Senior

Tech Stack

Cyber Security

About the role

  • Work cross-functionally to align quality and regulatory requirements throughout the medical device software lifecycle
  • Support the qualification and validation of digital tools and systems used within the QMS
  • Lead the implementation, maintenance, and user training of Qbtech’s eQMS system
  • Support the development and implementation of regulatory strategies
  • Perform internal audits and follow up on proposed improvements
  • Support companywide and employee specific training initiatives
  • Act as deputy to the Project Quality & Regulatory Manager.

Requirements

  • 7+ years in regulatory/quality roles for medical device software
  • Expertise in IEC 62304, ISO 13485, ISO 14971, EU MDR, FDA QMSR
  • Knowledge of software development, cybersecurity, and medical software architecture
  • Experience with international regulatory submissions.
Benefits
  • Hybrid work, minimum 3 days/week in Stockholm.
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory compliancequality management systemsqualification and validationinternal auditsregulatory strategiessoftware developmentcybersecuritymedical software architectureinternational regulatory submissionseQMS implementation
Soft Skills
cross-functional collaborationleadershiptrainingcommunicationorganizational skills
Certifications
IEC 62304ISO 13485ISO 14971EU MDRFDA QMSR