Regulatory Affairs & Compliance Manager

Overview

We are Neodent, a Brazilian brand and leader in dental implants in the country. For over 30 years, we have been contributing to creating thousands of new smiles every day. We are part of the Straumann Group and, in Brazil, we represent the brands Neodent, Straumann, ClearCorrect, and Yller. Our purpose is to create new smiles every day, and we achieve this guided by a cultural journey and a Protagonist & Learner mindset, which make our employees a high-performance team.

Responsibilities

• Support product development process and ensure compliance of development deliverables, including review of product requirements, verification and validation test plans and reports, product claims, product labels and instructions for use, applicability of standards, and design review milestones
• Compile the Regulatory Affairs (RA) Strategy
• Ensure that the technical documentation supporting the CE mark complies with MDR EU 2017/745
• Cre...