Clinical Affairs Manager (m/f/diverse)
Now’s our time to inspire the future of healthcare together.
We at Siemens Healthineers are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind.
While we are investing in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also investing in our 48.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in the healthcare industry.
Join our team now at Siemens Healthineers as Clinical Affairs Manager (m/f/diverse).
If you are ambitious and change makes you thrive, take on responsibility for our global Clinical Affairs.
- You will guide Siemens Healthineers (SHS) units in global regulations pertaining to the clinical evaluation of medical devices and performance evaluation of vitro diagnostic medical devices (IVDs) and providing hands-on guidance to the SHS units in compiling clinical evaluation and performance evaluation reports
- You will support SHS units in global clinical regulations pertaining to the clinical investigations, clinical studies and (clinical) performance evaluation studies, with primary focus on the European Union regulations. This includes support to the SHS units in establishing clinical development strategies, planning and conducting clinical investigations/studies, support in communication with the national competent authorities, ethics commissions and contract research organizations as well as counselling in qualification and monitoring of clinical investigation/study sites
- Furthermore, you will analyze global clinical regulations and establish/maintain SHS-wide policies and procedures that detail the conduct of required clinical activities
- You will communicate effectively new or changed clinical regulations to the global SHS clinical community
- You will create training concepts and prepare training material for global clinical processes. Moreover, you will provide trainings and coach SHS units and external customers, e.g. national competent authorities and clinical investigators
- You will work with local and international industry associations and standard organizations to harmonize global clinical regulations
- You will work as clinical monitor and clinical auditor in accordance to ISO 14155 in clinical investigation/study sites and/or support clinical investigation/study sites during an audit or inspection
- And you are willing to work on further regulatory affairs and quality management topics
This position may suit you best, if you already have several years of substantial work experience in Clinical Affairs.
- You have a university degree in human medicine or biology and/or equivalent qualification and experience and have then gained several years of substantial professional experience in a Clinical Affairs function or equivalent in the medical device/IVD industry, an academic clinical research center or a contract research organization. You understand very well the business needs of medical device/IVD industry and you have profound knowledge of the regulatory requirements for medical devices and IVDs
- You can demonstrate profound knowledge and practical experience in managing clinical investigations and/or (clinical) performance evaluation studies in European Union
- You have gained fundamental knowledge in the clinical research methodologies, including clinical investigation/study design, biostatistics, information management (e.g. use of scientific literature databases), and medical writing
- You are proficient in the most current version of MEDDEV 2.7/1 and ISO 14155
- You have profound skills in project management and you have very good communication and presentation skills
- You have already proven your capabilities and skills for leading interdisciplinary teams; you are trained and experienced in lateral leadership
- You show personal initiative and assertiveness; you are accustomed to work methodically and independently
- You have a goal-oriented working style and know how to employ your intercultural experience to accommodate different cultures and personalities in international teams. Thanks to your very good command of the German and English language you communicate easily with different stakeholders
- You are willing to travel internationally (about 10-20%)
If you want to join us in transforming the way healthcare is delivered, get in touch with us.
if you wish to find out more about the specific business before applying.
+49 (9131) 7-35335
if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Ilonka Schönemann.
if you would like to find out more about jobs & careers at Siemens Healthineers.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Job ID: 85800
Organisation: Siemens Healthineers
Experience Level: Experienced Professional
Job Type: Full-time