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Regulatory Affairs Expert
2 semanas atrás
About the Role
At TN Portugal, we are seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with applicable regulatory requirements.
Key Responsibilities
- Update and maintain technical documentation for medicinal products, adhering to EU guidelines and global regulatory frameworks.
- Collaborate with cross-functional teams to gather necessary documentation and data.
- Ensure all technical files are complete, current, and compliant with relevant laws and standards.
- Support quality and regulatory audits and inspections.
- Provide regulatory advice and guidance to project teams on requirements related to product design, labeling, or manufacturing processes.
- Monitor regulatory developments within the medical device field and advise on impact and necessary actions.
Requirements
- Minimum 1 year experience in Regulatory Affairs.
- Knowledge of local and European pharmaceutical legislation.
- Proficiency in English (B2 or higher) and knowledge of Spanish valued.
- Bachelor or Master's degree in Life Sciences industry.
