SOFMEDICA Life-saving Innovation

Quality & Regulatory Specialist

SOFMEDICA Life-saving Innovation

full-time

Posted on:

Location Type: Hybrid

Location: Sofia • Bulgaria

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About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality Management Systems (QMS)ISO 9001ISO 13485ISO 14001complaints handlingnon-conformities managementsupplier qualificationinternal auditingISO management systemsrisk management
Soft Skills
effective communicationteamworkattention to detailorganizational skillsresponsibilityflexibilitydynamic learningcontinuous improvement