Senior Expert

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?

**Then come and join our global team as**Senior Expert (f/m/d) Clinical Affairs**in the central quality department to support our business areas, business lines, business horizontals and technology units as well as country organizations. You will act as a strategic advisor and internal consultant across our global organization, supporting clinical affairs activities for medical devices and in-vitro diagnostic. A cross-functional role to enable advanced automated processes for compliant and effective clinical strategies across our manufacturing units and business functions.**

**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.**

**This position is full-time or part-time with a minimum of**28**h/week.**

**Your tasks and responsibilities**:

- Oversight of clinical affairs and quality activities across businesses to enable regulatory compliance supporting business growth.
- Independently provide expert consultation on clinical evidence strategies throughout the product lifecycle from development to post-market.
- Lead pro-actively efforts to digitalize and automate clinical affairs processes and tools with the goal of enhancing compliance, operational efficiency, and data quality across the organization.
- Ensure clinical activities align with global regulatory requirements (e.g., EU MDR/ IVDR, FDA, ISO 14155) to achieve market access.
- Identify and analyze trends and develop appropriate regulatory strategies for clinical determinations in a self-driven manner.
- Guide and review the planning and execution of clinical investigations and performance studies conducted by manufacturing units or third parties.
- Pro-actively monitor regulatory and normative changes related to clinical evidence, contribute to the creation and assess their impact on company strategy.
- Create quality requirements, guidelines and work instructions relevant for maintaining regulatory compliance in clinical aspects and provide training and templates to ensure consistent implementation across business areas.
- Represent the Clinical Affairs function in cross-functional and strategic initiatives at the global level as well as industry associations and standard organizations
- Collaborate with Regulatory Affairs, Medical Affairs, R&D, and Government Relations to ensure cohesive product and portfolio strategies.

**Your qualifications and experience**:

- You have a university degree in life sciences, medicine, biomedical engineering, or related field; advanced degree (e.g., MSc, PhD, MD) preferred.
- Minimum of 7 years of professional experience in a clinical affair, ideally in the medical device industry, with focus on imaging, therapeutic devices, or IVDs.
- Proven expertise in clinical evidence generation and evaluation under global regulatory frameworks (e.g., EU MDR/ IVDR, FDA).
- Experience supporting global product development and/or post-market surveillance strategies.
- Strong understanding of Good Clinical Practice (GCP) and relevant ISO standards (e.g., ISO 14155).
- You demonstrate profound knowledge and practical experience in managing clinical investigations and/or performance evaluation studies and bring experience in Post Market Clinical Follow Up

**Your attributes and skills**:

- Strategic mindset with a strong ability to balance compliance, business needs, and innovation.
- Excellent interpersonal and communication skills; capable of influencing and advising cross-functional stakeholders.
- High level of initiative and ability to work independently in a global matrix organization.
- An analytical and structured approach to problem-solving and decision-making.
- Your working style is purposeful, you are engaging and able to professionally lead teams with diverse cultures and personalities.
- Fluent in English and a good knowledge of German and other languages are an advantage.
- You are prepared to travel worldwide (max. 20%)
- You are passionate about learning - you are highly motivated to continuously improve processes and are open to change.

**Our global team**:
Siemens Healthineers is a leading global medical technology company. 73,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, labora