Regulatory Affairs Specialist Medical Software
hace 3 días
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 SpecialistWe'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.
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.
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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