Senior Expert (f/m/d) Clinical Affairs

Job title:

Senior Expert (f/m/d) Clinical Affairs

Company:

Siemens

Job description

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 28h/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.

To find out more about the specific business, have a look atYour 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
• Do you already have many years of in-depth professional experience and other qualifications in this field, but not a university degree? Then we look forward to your application.

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, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.Our culture:Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success. Check our Careers Site atAs an equal opportunity employer, we welcome applications from individuals with disabilities.Wish to find out more before applying? Contact us: +49 (9131) / 17 – 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Simone Morgenstern.We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click to get started.To all recruitment agencies:Siemens Healthineers’ recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.Siemens Healthineers Germany was awarded the Great Place to Work® certificate.

Expected salary

Location

Erlangen, Bayern

Job date

Wed, 02 Jul 2025 03:52:02 GMT

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