Regulatory Affairs Specialist generating regulatory submissions and managing compliance for medical device engineering projects at Teleflex. Ensuring adherence to FDA and Health Canada regulations with effective project timelines.
SI
Hybrid Quality & Regulatory Specialist
Posted 1 hour ago
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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