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Title

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Medical Compliance Specialist

Description

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We are looking for a Medical Compliance Specialist responsible for ensuring that medical documentation, processes, and products comply with established regulations and standards. Your role will be crucial in maintaining high levels of quality and safety in medical practice and production. You will collaborate with various departments, including clinical, legal, and manufacturing, to ensure all aspects of operations meet legal requirements and internal policies. Responsibilities include analyzing regulatory documents, preparing reports, conducting audits, and providing consultations on compliance issues. We expect the candidate to have deep knowledge of medical law, quality standards, and risk management, as well as the ability to work in a team and communicate effectively with different stakeholders. If you are eager to develop professionally in the medical field and want to contribute significantly to ensuring the safety and quality of medical services, we would be glad to have you on our team.

Responsibilities

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  • Ensure compliance of medical processes and documentation with regulatory requirements.
  • Analyze and interpret medical standards and legislation.
  • Prepare and maintain compliance reporting documentation.
  • Conduct internal audits and compliance checks.
  • Advise staff and management on medical compliance issues.
  • Interact with regulatory authorities and prepare for inspections.
  • Develop and update internal policies and procedures.
  • Train personnel on standards and requirements.
  • Monitor changes in legislation and standards.
  • Participate in the development of new products considering safety requirements.

Requirements

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  • Higher education in medicine or law.
  • At least 3 years of experience in medical compliance.
  • Knowledge of healthcare regulations and standards.
  • Ability to analyze and systematize information.
  • Skills in conducting audits and preparing reports.
  • Excellent communication and organizational skills.
  • Attention to detail and responsibility.
  • English proficiency at least at Intermediate level.
  • Experience with electronic document management systems.
  • Ability to work both independently and in a team.

Potential interview questions

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  • What experience do you have with medical regulations?
  • Which quality standards do you know and have applied?
  • Describe your experience conducting audits.
  • How do you track changes in legislation?
  • What methods have you used to train personnel?
  • How have you interacted with regulatory authorities?
  • Describe a situation where you resolved a compliance conflict.
  • Which software tools do you use for documentation?
  • How do you ensure accuracy and completeness of reporting?
  • What skills do you consider key for this position?