Commercial Quality Specialist LATAM (English CVs only)

LivaNova; São Paulo; Presencial; BRL 90.000 - 120.000; Tempo integral

Resumo da oferta

A global medtech company is seeking a Commercial Quality Specialist in Brazil to ensure compliance with regulatory requirements and quality standards in the medical device industry. The role involves managing safety reporting, ensuring Good Distribution Practices are met, and collaborating with global quality functions. Candidates should hold a relevant Bachelor's degree and have 3–5 years of experience, along with fluency in Portuguese and English. This position is critical for maintaining product quality and patient safety.

Qualificações

• Minimum of 3–5 years of experience in Quality, Regulatory, or Compliance.
• Solid understanding of ANVISA regulations and Good Distribution Practices.
• Familiarity with regulatory environments in Colombia is desirable.

Responsabilidades

• Manage and coordinate Adverse Event, complaint, and product safety reporting.
• Ensure compliance with ANVISA GDP requirements for distribution practices.
• Maintain and update regional quality procedures in alignment with corporate standards.
• Provide high-quality translations of documents and communications.

Conhecimentos

Fluent in Portuguese

Fluent in English

Analytical skills

Problem-solving skills

Documentation skills

Formação académica

Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Nursing, or related field

Descrição da oferta de emprego

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.

Please note we only accept CVs in English

The Commercial Quality Specialist will support the company’s commercial operations across Brazil, Chile, and Columbia by ensuring compliance with local regulatory requirements, quality standards, and safety reporting obligations for medical devices. This roleleven is critical to maintaining product quality, patient safety, and regulatory adherence, with a strong focus on Brazilian ANVISA regulations, Good Distribution Practices (GDP), and Adverse Event (AE) reporting for LivaNova’s Business Units (CP and NM).

This position requires close collaboration with regional commercial teams, distributors, global quality functions, and regulatory affairs partners.

Key Responsibilities

1. Safety Reporting & Vigilance

• Manage and coordinate Adverse Event flatter (AE), complaint, and product safety reporting activities for Brazil, Chile, and Columbia.
• Ensure timely submission of reportable events to health authorities, including ANVISA (Brazil), ISP (Chile), and INVIMA (Columbia).
• Maintain robust vigilance processes aligning with global and local regulatory requirements.
• Support product investigations by liaising with global complaint handling units and local commercial teams.

2. Regulatory Compliance & GDP (Good Distribution festgestellt Practices)

• Ensure compliance with ANVISA GDP requirements (RDC 430/2020, RDC 16/2013, and related regulations) for storage, transportation, and distribution practices.
• Conduct periodic distributor quality assessments (as applicable) and ensure proper implementation of quality agreements.
• Oversee local documentation required for quality compliance, including batch traceability, temperature logs, and product release (if applicable) for activities managed through 3rd party logistics partner.
• Support local licensing and regulatory submissions in collaboration with Regulatory Affairs teams.

3. Quality System Support

• Maintain and update regional quality procedures in alignment with corporate QMS standards.
• Support internal and external audits, including ANVISA inspections and distributor audits.
• Coordinate change management, field actions, and product recall as required.
• Monitor and support quality KPIs for the LATAM commercial organization.

4. Cross‑Functional Collaboration

• Partner with Commercial, Supply Chain, Customer Service, and Regulatory Affairs teams to ensure aligned quality oversight.
• Provide training to internal teams and distributors on vigilance, complaint handling, and GDP responsibilities.
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5. Documentation, Reporting, & Translation

• Prepare and maintain accurate quality documentation for the LATAM region.
• Provide high-quality translations (English ↔ Portuguese) of quality and regulatory documents, reports, and communications.
• Ensure clear, professional communication with both internal and external stakeholders in English and Portuguese.

Qualifications & Requirements

Education & Experience

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Nursing, or related field.
• Minimum of 3–5 years of experience in Quality, Regulatory, or Compliance within the medical device, pharmaceutical, or healthcare industry.
• Solid understanding of ANVISA regulations, including Good Distribution Practices (GDP) and vigilance requirements.
• Familiarity withייגן regulatory environments in Colombia (ISP) and Columbia (INVIMA) is desirable.

Language Skills

• Fluent in Portuguese and English (speaking, and writing).
• Spanish proficiency is a plus.

Technical & Professional Skills

• Knowledge of ISO 13485, ISO 14971, and global medical device quality regulations.
• Strong documentation, problem-solving, and analytical skills.
• Ability to work independently and manage multiple priorities across countries faill.

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