RAQA Analyst - Latam (VILA LEOPOLDINA)

Carrying out, controlling and implementing activities related to the company's quality system.

Carrying out, controlling and implementing the regulatory processes applicable to the company's activities and products.

Providing support to the RAQA manager in the department's activities.

1. Establishment and Product registration, change / amendment, renewal and local operation licenses

   1. Support the preparation of dossiers for product/licenses notification/registration, renewals and/or changes.
   2. Track and monitor the regulatory submission status to ensure on-time approval.
   3. Keep Global RAQA systems/database updated, on real

2. Labelling and Advertisement 

   1. Review product labelling and instruction of use (IFU) to ensure compliance with corporate and local regulatory requirements. 
   2. Review advertisement / sales promotional materials to ensure compliance with corporate and local regulatory requirements. 
   3. Support the preparation of dossiers for advertisement material submission process to obtain approval from local Health Authorities.

3. Post Market Vigilance - Complaint, Adverse Event (AE), Field Safety Corrective Action (FSCA), Recall 

• Report product complaint to manufacturer, addressing product complaint from customer to manufacturer, monitor the status until closure.

4. Quality Assurance

• Support to maintain the local Quality Management System (QMS) in compliance with the corporate global and local requirements. 
• Perform the quality activities according to demand: procedures control, product complaints, non-conformities, environmental control, product reception, nationalization, or any other activities related to QMS.
• Support in receiving external audits and conduct self-inspections according to the applicable audit standard.
• Support RAQA trainings to stakeholders, if requested. 

5. Others

• Prepare RAQA reports on a regular/monthly basis.

• Maintain the administrative processes related to payments and contracts (Purchase orders) for local RAQA supplier / providers.

Travel: 

• Occasional trips, less than 5% of the time.

• Good written and verbal communication skills and interpersonal relationship skills.

• Good attention to detail.

• Availability to work in the office.
• Good knowledge in Microsoft Office Suite including Word, PowerPoint and Excel.
• Knowledge of local and global regulations relevant to medical devices. 
• Ability to build productive internal/external working relationships.
• Comply with company policies, procedures and values.

• Ability to work effectively either alone or as part of a team. 

• Ability to read, write and speak English and Spanish. 

Work Environment:

• Able to work long periods of time in a normal office environment, while sitting and working on a computer.

Experience:

• Minimal of 1 year experience in Regulatory Affairs and Quality Assurance in Latam countries.

Education:

• Graduated or studying - pharmacy or another health area.

Knowledge of the VEEVA RIM system is a plus.