Regulatory Affairs Specialist Medical Software

hace 3 días


Barcelona, Barcelona, España Qmenta A tiempo completo
About Qmenta

We are a fast-growing start-up developing technologies to better understand the brain.

Competitive Salary and Flexible Work Environment

$**120,000 - $180,000** per year based on experience, with flexibility of working hours within our hybrid model.

Job Description: Quality Assurance & Regulatory Affairs Specialist

We're seeking an experienced Quality Assurance & Regulatory Affairs Specialist (Medical Software) to join our team. As a key member, you will be responsible for ensuring all activities follow global quality standards and regulations. Your role includes:

  • Maintaining our Quality Management System (QMS) according to ISO 13485, IEC 62304, FDA Title 21 CFR Part 11&820, Annex 11, EU GDPR, US HIPAA, ICH E6 (R3) GCP, and GxPs.
  • Leading/coordinating Management Review Meetings.
  • Measuring and evaluating quality KPIs.
Requirements

To succeed in this role, you'll need:

  • At least 5 years of professional experience as a QARA specialist, ideally in medical software.
  • A deep understanding of Quality Management Systems (ISO 13485, FDA Title 21 CFR Part 820).
  • Leadership experience in internal audits and certification support.
  • Knowledge of FDA and CE marking regulations, especially 510(k) submissions.
  • Familiarity with regulated software development life cycles (IEC 62304, IEC 82304) and healthcare sectors.
Benefits

We offer a competitive salary, flexible work environment, health insurance coverage, flexible remuneration package, weekly breakfast, and team-building opportunities. If you want to contribute to a positive impact in the biotech industry with an internationally highly qualified team, Qmenta is your place.



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