Regulatory Affairs Specialist

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 LATAM RAQA manager in the department's activities.

Essential Functions & Accountabilities:

 

• Prepare and review dossiers for product notification/registration, renewals and/or changes;
• Active involvement with new projects and new product developments.
• Proper evaluation of technical documents, change controls, dossiers, gap assessments, etc.
• Identify trends, assess impact, analyze alternatives and recommend action plans
• If necessary, acts as Technical Responsible Person in front of Brazilian authorities
• Control and renew the company's operating licenses and permits;
• Review and approve marketing and commercial materials.
• Provide regional regulatory input during cross functional business projects.
• Involvement with local competent authorities and trade associations on an as needed basis. 
• Responsible for developing the regulatory intelligence plan: monitoring, evaluating and reporting on publications and changes relating to the business.
• Support of regional, and as needed global, regulatory demands to the different internal stakeholders.
• Prepare, review and monitor procedures for the Quality Management System (RDC nº665/22);
• Support quality activities according to demand: product complaints,  non-conformities, environmental control, product reception, nationalization, internal audits.
• Receive internal and external audits
• Assures proper decision making in case of Quality issues
• Assure CVB quality system is aligned with ISO 13485 and MDSAP requirements
• Responds to corporate inquiries and follow up to internal processes: RAID, PRCO, PCO´s
• Support RAQA analyst, being a focal point for technical matters.   

 

Travel: 

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

   

Work Environment:

• Prolonged sitting in front of a computer

Knowledge, Skills and Abilities:

 

• Knowledge of quality systems and good manufacturing, storage and distribution practices for medical products;
• Availability to work in the office;
• Advanced knowledge in Microsoft Office Suite including Word, PowerPoint and Excel - advanced
• Good problem-solving, decision-making, organizational, analytical and critical thinking skills
• Good written and verbal communication skills and interpersonal relationship skills
• Ability to read, write and speak English (advanced) and Spanish (basic); 
• Solid knowledge and understanding of local and global regulations relevant to medical devices 
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to build productive internal/external working relationships
• Adhere to all company rules, requirements and policies. 

 

 

Experience:

• Minimal of 5 years’ experience in Regulatory Affairs and Quality Assurance, minimum of 02 years in the position. Experience with other Latin American countries would be a plus.

 

Education:

• Graduated in pharmacy or another health area.
• Registration with an active professional council.