Quality and Regulatory Compliance Specialist AV South LATAM
hace 1 mes
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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