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Regulatory Affairs Specialist Manager

Curitiba Permanente Descrição da vaga
As a Regulatory Affairs Specialist Manager, you will play a key role within global product development projects, ensuring compliance with regulatory requirements across multiple markets, including Europe, the United States, and Canada.Despite the managerial title, this is an individual contributor role, requiring strong autonomy, ownership, and the ability to operate effectively in a global, matrix environment.

Atualizada 14/05/2026

  • Regulatory Affairs experience within the Healthcare & Life Sciences industry
  • Advanced/Fluent English

Sobre nosso cliente

A global leader in the dental and medical devices industry, recognized for its innovation, high-quality standards, and strong expertise in highly regulated environments.

With a well-established international presence, the company operates in a truly global structure, connecting teams across Latin America and Europe and contributing to solutions that positively impact patients worldwide.

Descrição

  • Act as the regulatory representative in cross-functional product development teams
  • Ensure compliance of product documentation, including requirements, verification and validation activities, labeling, and instructions for use
  • Develop and implement regulatory strategies for global product registration
  • Prepare and maintain technical documentation for CE marking and ensure compliance with EU MDR (2017/745)
  • Support regulatory submissions and approvals in the US (FDA) and Canada
  • Monitor and ensure compliance with applicable international regulations and standards
  • Provide regulatory guidance and interpretation to internal stakeholders
  • Support audits and interact with regulatory authorities and notified bodies
  • Assess product changes and ensure ongoing regulatory compliance throughout the product life cycle

Perfil desejável

  • Bachelor's degree in a scientific or technical field such as: Pharmacy, Biomedical Engineering, Biomedicine, Life Sciences or related disciplines;
  • Solid scientific and regulatory foundation, preferably within healthcare or medical devices.
  • At Least 5 years professional experience in Regulatory Affairs and/or Quality Management
  • Advanced/Fluent English (written and spoken).



Technical Skills (Desirable)

  • Knowledge of key regulatory standards and frameworks: ISO13485, ISO 14971, EU 2017/745, 21 CFR, SOR 98-282
  • Strong analytical skills with the ability to review and assess technical documentation
  • Understanding of product life cycle from a regulatory perspective



Soft Skills

  • High level of autonomy and ownership
  • Strong communication and stakeholder management skills in global environments
  • Analytical mindset and attention to detail
  • Hands-on and execution-oriented profile
  • Ability to work under pressure and manage multiple priorities
  • Adaptability in a dynamic, matrix organization

O que está sendo ofertado

CLT regime - (R$)

Contato
Marcelly Mendes
Referência da Vaga
JN-052026-7012176

Resumo da vaga

Setor
Saúde & Life Sciences
Subsetor
Medical Devices
Indústria
Healthcare / Pharmaceutical
Localização
Curitiba
Tipo de contratação
Permanente
Nome do consultor
Marcelly Mendes
Referência da vaga
JN-052026-7012176