Regulatory Affairs Expert

Há 2 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$120.000 - R$160.000
Job Title: Quality Assurance Regulatory Affairs Manager

This role oversees quality assurance and regulatory compliance for our operations in Brazil, ensuring local alignment with global regulations and standards as well as corporate alignment with Brazilian regulations and standards.

Main Responsibilities:
  • Ensure Compliance with Brazilian regulatory requirements per ANVISA standards for product registration, licensing, and post-market surveillance.
  • Prepare, submit, and manage regulatory dossiers for product approvals, renewals, and significant changes in Brazil.
  • Liaise with ANVISA and other regulatory bodies as the primary point of contact and Technical Responsible person in Brazil.
  • Monitor changes in Brazilian and Latin American regulations and advise on their impact to our company operations.
  • Work with US based team members to develop global procedures that appropriately capture Brazilian requirements.
Quality Assurance Responsibilities:
  • Maintain and improve the local Quality Management System in accordance with Brazilian GMP and international standards.
  • Partner with corporate quality and regulatory teams to ensure global alignment of policies and procedures.
  • Conduct internal and external audits to ensure compliance with Quality Standards.
  • Manage Non-Conformances (NCs) and Corrective Action/Preventive Actions (CAPAs) to resolve quality issues for the Brazilian site.
  • Support global NCs and CAPAs to resolve quality issues which impact Brazil and Latin American markets.
  • Ensure proper documentation and record keeping for quality and regulatory processes within the Brazilian site and at any 3rd party logistics providers in Brazil.
  • Implement Vigilance systems to track product performance on the Brazilian Market.
  • Organize and run Brazilian Management Review meetings.
  • Provide training to local staff on regulatory requirements and quality standards.
Required Skills and Qualifications:
  • Fluent in Portuguese and English (written and verbal); Spanish is a plus.
  • Ability to communicate effectively with cross-functional teams, international teams, company leadership, distributors, and regulatory authorities.
  • Strong knowledge of Brazilian regulatory and quality requirements.
  • Working knowledge of global regulatory and quality requirements.
  • Ability to lead a team, influence others, and handle increasing levels of responsibility.
  • Understands the overall business environment, the orthopedic industry, and the marketplace. Direct experience with spinal implant companies is a plus.
  • Ability to identify and assess business risks to develop Regulatory strategy
  • Ability to manage/supervise employees and consultants.
  • Excellent project management and problem-solving skills.
  • Strong computer skills.
Benefits:

We offer a competitive salary and benefits package including opportunities for professional growth and development.

Travel Requirements:
  • Up to 15% travel may be required.

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