# Quality & Regulatory Specialist

> SOFMEDICA · Sofia, Bulgaria (Hybrid) · Full-time · Posted 2026-03-06

**Workplace:** hybrid

**Department:** Compliance

## Description

SOFMEDICA is a leading regional multinational company that distributes innovative medical equipment harnessing the power of precision to improve healthcare outcomes. We are deeply committed to bridging the gap between cutting-edge medical technology and patients in Central and Southeastern Europe.

We are looking for a Quality and Regulatory Specialist to join our team and contribute to the quality and compliance of our medical devices.

**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 / Regulatory Specialist** role, preferably within a **regulated industry** (e.g., medical devices, pharmaceuticals, manufacturing, or environmental management).
-   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 Bulgarian and English

**Offer:**

-   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.

## Apply

[Apply at SOFMEDICA](https://apply.workable.com/sofmedica/j/15BF8700FB/apply)

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