Job Description
- 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
CLT regime - (R$)