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

Siemens Healthineers AG

• Forchheim - - Alemania

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting?

Choose the best place for your work – 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.

Even more flexibility? 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 28h/week.

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 organizations, 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.
• 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.

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. #myabilityshs