Analyst Regulatory Affairs- Fixed term 12 months

Há 6 dias

São Paulo, São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

São Paulo, Brazil

Job Description:

Main Responsibilities:

  • Serve as the main interface of Regulatory Affairs with Commercial Quality, handling non-conformance, change controls and procedures, as well as providing all applicable support to local and international audits/ inspections, especially from ANVISA, INMETRO and MDSAP.
  • Responsible for verifying product codes that have local ANVISA product license and determining which variations can be imported. Interface with regional LATAM Reg. Affairs team to release the applicable product versions.
  • Analysis of promotional materials according to ANVISA regulation.
  • Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates.
  • Interacts with other JJ stakeholders, government agencies in a professional, decisive, & articulate manner.
  • Act as a point of contact for stakeholders to support business plans and regulatory needs.
  • Review labels compliance in internal system.
  • Support implementation and regulatory assessment of new regulations.
  • Lead projects or support projects as representative of the subject/country.

Qualifications:

  • Previous experience in Regulatory Affairs in Medical Devices (or Drugs/ cosmetics and food).
  • Knowledge of Local Regulations from Medical Devices (or Drugs/ cosmetics and food).
  • Bachelor's Degree in Engineering, Pharmacy or other life science related.
  • Strong analytical and investigation skills.
  • Strong prioritization and collaboration skills.
  • Advanced level of English. Spanish will be a plus.
  • Desirable experience in Medical Devices, ANVISA and INMETRO regulations.
  • Desirable experience in Quality, such as non-conformances, audits, change controls and procedures

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Collaborating, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments

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