Join LegalVision as a motivated lawyer (2 - 4 PQE) in the Commercial and Regulatory Practice. Work with NDIS providers and healthcare organizations to navigate complex regulatory requirements.
SI
Hybrid Quality & Regulatory Specialist
Posted last month
About the role
- Quality and Regulatory Specialist managing quality management systems for medical devices at SOFMEDICA. Ensuring compliance with regulations and overseeing audits and supplier qualifications.
Responsibilities
- Manage and maintain the company’s **Quality Management Systems (QMS)** in accordance with **ISO 9001, ISO 13485, ISO 14001**, and other relevant standards.
- Oversee the **handling of complaints and non-conformities**, ensuring timely investigation, documentation, and implementation of corrective and preventive actions.
- Manage and control **certificates, technical documentation, and quality records** to ensure compliance and traceability.
- Supervise **supplier qualification, evaluation, and contract management**, maintaining strong relationships and ensuring compliance with quality and regulatory requirements.
- Coordinate and maintain effective **communication with competent authorities** and regulatory bodies.
- **Participate in internal and external audits**, supporting preparation, execution, and follow-up of audit activities.
Requirements
- University graduate
- **Experience** in a **Quality Assurance / Internal Auditor (SOX)** role, preferably within a **regulated industry** (e.g., medical devices, pharmaceuticals, manufacturing, or environmental management). Regulatory Specialist experience can be advantage.
- Proven experience in maintaining and improving **ISO management systems**
- Strong understanding of **quality management principles**, **risk management**, and **continuous improvement methodologies**.
- Dynamic and fast learner
- Capacity to **communicate effectively** and the ability to work in a team
- Responsible for own work, well-organized, with attention to details, familiar to work according to the procedures
- Flexible to work in dynamic environment
- Fluent in Hungarian and English
Benefits
- Be part of a mission-driven team dedicated to improving healthcare.
- Opportunity for professional growth and continuous learning.
- A supportive and innovative work environment.
- Competitive salary, bonuses, and comprehensive benefits.
- Opportunities for professional development and career advancement within SOFMEDICA Group.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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