Regulatory Affairs Associate (M / F) - Lisboa

Job Description

As a Regulatory Affairs officer, your responsibilities will include :

• Update and maintain technical documentation for medicinal products in accordance with applicable regulatory requirements, including but not limited to the EU guidelines, and other global regulatory frameworks.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to gather necessary documentation and data.
• Ensure all technical files are complete, current, and in compliance with relevant laws and standards.
• Support the quality & regulatory department (QARA), in audits and regulatory inspections.
• Provide regulatory advice and guidance to project teams on regulatory requirements, especially related to changes in product design, labeling, or manufacturing processes.
• Monitor regulatory developments within the medical device field and advise on impact and necessary actions.

Job Requirements :

Please apply by sending your CV through our portal.

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