Regulatory Affairs Specialist

CooperVision Limited; São Paulo; Hybrid; BRL 90.000 - 150.000; Vollzeit

Zusammenfassung

CooperVision Limited in Brazil seeks a senior Regulatory Affairs and Quality Assurance professional to lead regulatory activities and align the quality system with ISO 13485 and MDSAP requirements. You will prepare dossiers, manage licenses, and support cross-functional projects to ensure compliant product introductions and lifecycle management.

The role requires advanced English, basic Spanish, and at least five years in RA/QA with medical devices.

Qualifikationen

• Knowledge of quality systems and GMP/GLP practices for medical devices.
• Must be office-based with availability to work in the office.
• Advanced MS Office (Word, PowerPoint, Excel).
• Strong problem solving, decision making, organizational, analytical and communication skills.
• English advanced and Spanish basic.
• Understanding of local and global regulations for medical devices.
• Attention to detail and professional interaction across levels.

Aufgaben

• Prepare and review dossiers for product notification/registration, renewals and/or changes.
• Active involvement with new projects and new product developments.
• Evaluate technical documents, change controls, dossiers, and gap assessments.
• Identify trends, assess impact, analyze alternatives and recommend actions.
• Act as Technical Responsible Person with Brazilian authorities when needed.
• Review and renew operating licenses and permits; approve marketing materials.

Jobbeschreibung

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.

Responsibilities

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.

• Prolonged sitting in front of a computer

Qualifications

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.

Job Info

• Job Identification 12145
• Posting Date 07/29/2026, 03:26 PM
• Apply Before 09/30/2026, 03:00 AM
• Job Schedule Full time