Your tasks

• You prepare and submit applications for conformity assessment procedures and clinical trials for non-active Class III implants.
• You coordinate timely and technically sound answers to inquiries from Notified Bodies and Competent Authorities.
• You create, evaluate and update CE-technical documentation as well as dossiers for clinical trial applications, also including supplier documentation.
• You advise cross-functional development teams on quality, analytical, preclinical and clinical requirements for regulatory submissions.
• You create and maintain product information in accordance with Company Core Data, applicable legislation and relevant guidelines.
• You manage the regulatory lifecycle of CE-marked products, including renewals, change notifications, and annual updates.
• You assess the regulatory impact of changes in production, marketing, and other internal areas.
• You coordinate regulatory projects and work with external partners, including consultants, CROs and sales partners.
• You develop regulatory strategies, contribute to cross-functional project teams, and are the contact person for regulatory requirements.
• You identify country-specific requirements within the EU beyond the CE marking and are responsible for the corresponding documentation.

What you bring

• A degree in natural sciences, pharmacy, biology, chemistry, medical technology/bioengineering or a comparable field, ideally a Master's degree or doctorate.
• Professional experience in EU regulatory affairs for Class III medical devices
• A sound understanding of the European regulatory landscape for medical devices
• Experience in direct interaction with Notified Bodies and/or authorities – regardless of whether this experience was gained at a manufacturer, a notified body or in regulatory affairs consulting.
• Excellent time management skills, structured problem-solving abilities, and confident use of digital tools.
• Independent, resilient and solution-oriented work style
• Ability to coordinate across functions and to convince stakeholders even without direct authority to give instructions.
• Fluent business English, both spoken and written