Quality and Regulatory Compliance Specialist Av

hace 7 meses


Bogota, Colombia Abbott Laboratories A tiempo completo

**_MAIN PURPOSE OF ROLE_**

Individual contributor that works under limited supervision.

**_ MAIN RESPONSIBILITIES_**
- Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
- Ensures compliance to the requirements from regulatory agencies.
- Maintains the technical and non-technical documentation change system.
- Assures procedures are in place to classify and maintain records.
- Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
- May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.
- May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.
- May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.



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