Quality and Regulatory Specialist

5 days ago

Budapest, Budapest, Hungary SOFMEDICA Life-saving Innovation Full time 400,000 - 800,000 per year

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 Hungarian 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.

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