* 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$)
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