Quality and Regulatory Compliance Specialist AV South LATAM

hace 1 mes


Bogota, Colombia Abbott Laboratories A tiempo completo

MAIN PURPOSE OF ROLE

Individual contributor that works under limited supervision.

Applies subject matter knowledge.

Requires capacity to understand specific needs or requirements to apply skills/knowledge.

MAIN RESPONSIBILITIES

â¢Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.

â¢Ensures compliance to the requirements from regulatory agencies.

â¢Maintains the technical and non-technical documentation change system.

â¢Assures procedures are in place to classify and maintain records.

â¢Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.

â¢May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.

â¢May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.

â¢May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

 



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