Regulatory Affairs Manager (all genders)

Your role:

People Manager for Böblingen within the Hospital Patient Management (HPM) Regulatory organization, with a particular focus on Digital Platforms and Operations.

Strategic Regulatory leader, planner, and Subject Matter Expert (SME) at the junior management level.

Leader managing Subject Matter Expertise within the HPM Regulatory organization, responsible for interpreting regulatory requirements for digital platforms supporting labeling (eIFU, eLabels, License Management platforms such as Sentinel) and partnering closely with Regulatory Affairs Specialists who incorporate applicable requirements and implement them into specific products.

Provides training to appropriate HPM employees on the understanding, interpretation, and implementation of US, European, and global standards and regulations applicable to cloud-based digital platforms for eIFU, eLabels, license management, and related systems.

Manages country-specific release requirements for cloud-based digital delivery management platforms, optimizing the current Pro-Co setup for digital deliveries and Synergy-related software releases.

Establishes regulatory processes and procedures to be used not only by Regulatory professionals but also by cross-functional partners to ensure products comply with applicable standards and regulations, including providing the necessary training to support digital platform implementation and operationalization.

Works closely as a key leader, interfacing with peers in R&D, Quality, Regulatory, Marketing, and global regulatory teams across all aspects of the product lifecycle, with a strong focus on global compliance for digital platforms.

Provides Regulatory Operational services to HPM Regulatory professionals to centralize administrative tasks and drive digital platform and operations initiatives, including:

• Registration prioritization dashboards

• RIMS/Rimsys management

• EUDAMED and GUDID database management

Utilizes state-of-the-art tools such as Power BI, ReedTech, and KAIROS (AI tools) for assigned products and projects.

You're the right fit if:

Bachelor’s or Master’s degree in Regulatory, Labeling, IT / Database Management, or an equivalent field.

10+ years of Regulatory experience, including management of IT tools supporting labeling, IFU, and digital platforms for operational processes such as device master records, device history records, and license management systems.

Demonstrated expertise in interpreting and implementing global medical device regulations and standards related to eIFU, eLabels, master database management for UDI, and establishment registration.

Strong experience in process improvement, process implementation, and facilitation of critical meetings.

Project management experience is required.

Strong knowledge and application of Quality Management Systems (QMS), including ownership of business processes and regulatory elements.

Proven coaching and mentoring skills with the ability to develop regulatory talent.

Fluent in English.

Cross-functional influence and advisory experience is highly desirable. 3–5 years of leadership or program management experience is preferred.

Knowledge across Regulatory, IT, Labeling, and Database systems.