Regulatory Expert (m/f/d)

You are responsible for continuously monitoring regulatory requirements concerning our products and work closely with our technical product developers and supply chain to ensure compliance. You represent the company in industry associations (e.g. BioPhorum) and are the contact person for our customers' regulatory questions.

Your tasks

• Monitoring and communication of relevant regulatory requirements from international pharmacopoeias (such as EP, USP), material-related regulations (e.g., REACH, PFAS), and relevant legal requirements
• Central point of contact for internal interfaces and external stakeholders (customers, suppliers, certification bodies)
• Representing the company in industry associations such as BioPhorum, active participation and collaboration in selected working groups
• Conducting regulatory assessments and risk evaluations of products and components, as well as for product changes
• Review of Quality Agreements
• Contributing to the continuous improvement and expansion of the certified integrated management system

Education

• Completed higher technical or scientific education
• Relevant professional experience in a regulated sector (e.g., pharmaceutical industry, medical technology, or similar)
• Sound knowledge of product/material regulations, ideally concerning consumables and process equipment in the biopharmaceutical sector
• Relevant knowledge of current best practices in regulatory CMC documentation is advantageous
• Knowledge of relevant management systems (ISO 9001, 14001)
• Business-fluent in English and German