Teamlead Regulatory Affairs - Global Market Access (f/m/d) Software as a Medical Device

Teamlead Regulatory Affairs - Global Market Access (f/m/d) Software as a Medical Device

Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours. Mobile working from abroad is possible for up to 30 days a year under certain conditions and in selected countries. This position is full‑time or part‑time with a minimum of 28 h/week.

Your tasks and responsibilities:

• You lead the international Regulatory Affairs team with a focus on global market access and drive its continuous development.
• You coordinate the analysis of country‑specific regulatory requirements and derive appropriate market access strategies.
• You ensure global compliance by collaborating independently with country organisations, Corporate Regulatory Affairs, and various functions within the Digital & Automation Business Line.
• You manage regulatory projects (e.g., implementation of new requirements such as MDR) and drive strategic adaptations to ensure faster market entry.
• You ensure continuous and timely market access in all international markets, supporting a smooth sales start after product launch.
• You are responsible for the approval of new products, assess risks to existing approvals, and communicate these clearly and purposefully.
• You prepare comprehensive status updates and decision‑making materials for the Digital & Automation management team.

Your qualifications and experience:

• You hold a university degree in law, medicine, engineering, or another relevant scientific discipline.
• You bring many years of professional experience in the healthcare sector or a related environment.
• You are highly familiar with regulatory frameworks such as MDR, ISO 13485, and QSR.
• You have in‑depth knowledge of international approval processes and market access strategies.
• You also bring proven experience in functional leadership, e.g., through leading project teams or coordinating specialist work packages.

Your attributes and skills:

• Your profile is complemented by excellent verbal and written English skills.
• You communicate clearly, persuasively, and in a target‑group‑oriented manner – both internally and externally.
• You lead and motivate your team confidently and foster a professional, collaborative work environment.
• You work in a structured, strategic, and solution‑oriented manner and maintain an overview even in complex situations.
• You act proactively and independently, drive topics forward, and ensure continuous development.
• You combine resilience with sound decision‑making and remain focused and reliable under time pressure.

As an equal‑opportunity employer, we welcome applications from individuals with disabilities.