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<body> <h1>Regulatory Affairs Manager (m/f/d)</h1> <h2>Bausch & Lomb GmbH, Heidelberg</h2> <p> Naturwissenschaften Medizintechnik Dokumentation, Redaktion Weitere Fachkraft Wiley Pharma, Chemie, Med., Biotechn. Produktmanagement Quality Manager Qualitätskontrolle Geschäftsfeldentwicklung Business Development Produktzulassung Biologie Chemie Pharma Qualitätsmanagement QM Angestellter o. Leitungsfunktion Wirtschaftsingenieurwesen Ingenieurwesen Physik Wirtschaftsingenieure Completed Degree in an Engineering or Natural Science 5 years medical device regulatory experience with EU MDD/MDR and US FDA Experience in communication with notified bodies and authorities Must possess at least an advanced level of performance in the majority of the following core competencies: influence key stake holders, business acumen, project management, relationship building, regulatory expertise Experience of creating and maintaining technical documentation Knowledge of the admission requirements according to MDD and MDR Basic knowledge of DIN EN ISO 13485 Structured and thorough work attitude Advanced computing skills including Word, Excel, Outlook Email Excellent written and verbal communication skills in German and English Textdesign, technical writing Art (Berufsfeld) Langjährige (> 7 J.) Ingenieur/Techniker Creating and updating technical documentation for CE Mark in accordance with EU MDR 2017/745 Person Responsible for Regulatory Compliance (PRRC) per Article 15 EU MDR 2017/745 Providing regulatory guidance during the entire life cycle of Medical Devices Monitoring and assessing regulation and standard changes to ensure continued compliance Manage/support worldwide market access: USA, Canada, Japan, Australia, APAC, Middle East, etc. Ensure implementation of proposed preclinical, manufacturing variation/change of products in registered countries to maintain the continuous compliance Developing regulatory related SOPs for Quality Management System Supporting QMS audit and inspection Heidelberg Mehrjährige (3-7 J.) Unternehmen Regulatory Affairs Manager (m/f/d) Vollzeit Sonstige k.A. Baden-Württemberg Abitur Creation and updating of technical documentation for CE Mark in accordance with EU MDR 2017/745 Vertrieb, Marketing, Medien Weitere Fachrichtungen Universitätsstudium Andere Berufsbereiche Industrie / Dienstleister Medien, Grafik, Design, Druck Deutschland Mathe, Naturw., Umwelt Fachhochschulstudium Qualitätswesen, Zulassung 69115 anderes Studium false Technische Berufe, Ingenieurwesen Sonstige Branchen Heidelberg <69120> Gebiet (Branche) Englisch Mathematik Handwerk, Fertigung, Inbetriebnahme Fertigung, Inbetriebn., Qualitätsw. </p> </body>