Regulatory Compliance Specialist

Há 2 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro US$100.000 - US$150.000

Job Title:

Regulatory Compliance Manager

About the Role:

We are seeking a highly skilled Regulatory Compliance Manager to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and developing quality service and compliance programs.

Key Responsibilities:

  • Provide temperature control and humidity requirements input and guidance to transportation partners.
  • Liaise with regional and global partners to develop quality service and compliance programs.
  • Support timely and accurate metrics and reports according to J&J policies for the transportation team.
  • Identify opportunities for continuous improvement in quality, cost, and time.
  • Oversee controls and quality standards implementation for transportation, ensuring local health authority requirements are integrated into transportation processes.
  • Manage inspections related to transportation by health authorities (e.g., COFEPRIS, INVIMA, ANVISA), third parties, and JJRC.
  • Collaborate with Global Transportation and Quality teams to investigate temperature excursions and quality issues, including remediation activities for inbound shipments.

Requirements:

  • Bachelor's degree in pharmacy, engineering, or scientific discipline.
  • Master's degree in engineering, science, or business (preferred).
  • Minimum of 5 years' experience in Quality Assurance.
  • Fluent in Spanish and English.
  • Experience in regulated healthcare industry, focusing on quality transportation, temperature control, and compliance.
  • Knowledge of applicable regulations such as ISO 9001, ISO 13485, Good Distribution Practices, and other healthcare regulations.
  • Strong planning skills and project leadership experience.
  • Problem-solving and decision-making skills.
  • Experience in issue investigation and remediation.

Work Environment:

This is a full-time position at Johnson & Johnson MedTech.

The ideal candidate will have experience working in hospitals and healthcare industries.

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