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. Sound interesting?
Then come and join our global team as Clinical Affairs Manager (m/f/d) to support Computed Tomography (CT) departments (e.g. Marketing, Development, Quality, Product Lines) in global clinical regulations pertaining to the clinical investigations, clinical studies and (clinical) performance evaluation studies, Post Market Clinical Follow UP activities, and Post Market Surveillance activities with primary focus on the European Union regulations.
Your tasks and responsibilities:
- This includes support to the departments 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.
- Support CT departments (Marketing, Development, Quality, Product Lines) in regard to Post Market Clinical Follow up and Post Market Surveillance activities.
- Execution of clinical evaluation and creation of clinical evaluation reports including the execution of literary research and the appraisal of the found sources
- Goal-oriented collaboration with (European) authorities as well as clinical and industrial partners.
- Communicate effectively new or changed clinical regulations in the whole CT organization and provide trainings
To find out more about the specific business, have a look at Computed Tomography
Your qualifications and experience:
- You have an university degree in human medicine or biology and/or equivalent qualification and experience
- You have relevant long-term professional experience in the medical device/ IVD industry, an academic clinical research center or a contract research organization
- 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
Your attributes and skills:
- You consider personal initiative and assertiveness natural; you are accustomed to work methodically and independently
- You have goal-oriented working style and know how to employ your intercultural experience to accommodate different cultures and personalities in international teams
- You have very good command of the German and English language; written and spoken
- You understand very well the business needs of medical device/IVD industry
- Of course you are very strong in communication and presentation
Depending on the experience- and qualifications background of the applicant, task enrichment into the area above the general pay scale is possible.
Our global team:
Siemens Healthineers is a leading global medical technology company. 50,000 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 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 at www.healthcare.siemens.de/careers
As an equal opportunity employer, we welcome applications from individuals with disabilities. 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 Marlena Maier.
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To all recruitment agencies:
Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
Job ID: 112628
Organization: Siemens Healthineers
Experience Level: Experienced Professional
Job Type: Full-time