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Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
A key role in a key role in ensuring thepositive impact of our MRI products on public health within the ProductManagement and Marketing team at Siemens Shenzhen Magnetic Resonance.
The Medical Officer and Clinical LifecyleManager at SSMR is responsible for the Clinical Evaluation & Lifecylemanagement of SSMR Legal Manufactured products. The individual is responsiblefor the process to continuously monitor and verify the device’s clinicalperformance and safety throughout the complete lifecycle of the device for boththe European DoC and the NM PA Clinical performance management.
- Manage the clinical evaluation of ourproducts for their release and launch to the global market.
- Manage and perform gap analysis fornew product clinical performance and advise project team on clinical evaluationrequirements
- Responsible for the evaluation ofclinical data for new product clinical evaluations.
- Responsible for post-market clinicalfollow up plan and strategy.
- Responsible for the clinical lifecyclethroughout the lifecycle of SSMR product portfolio.
- Continuously monitor and verify thedevice’s clinical performance and safety as part of post-market clinical followup
- Responsible for the ClinicalEvaluation and Clinical Lifecyle Management process according to Medical DeviceRegulation and NMPA regulations. Working closely with counterparts in Erlangenand quality department to establish a harmonized process.
- Post market clinical follow up processat SSMR and will work closely with project teams in SSMR and counterparts inErlangen.
- Responsible for the product Survey andAnalysis report of SSMR products to ensure that market feedback is incorporatedinto our product development.
- Responsible keeping up to date withlatest regulatory body clinical evaluation requirements and standards andincorporating them into our process and lifecycle management
- Identification of clinical growthareas, taking into account the medical requirements of referring physicians aswell as radiologists, patients and funding bodies. Initiation and support ofrelevant (preliminary) development projects including accompanying publications.
- Good level of English language skills both spoken and written
- Qualifications / work experience that provides necessary knowledge and experience in Patient Care and MRI Clinical Application. (e.g. MR technician, MR Application specialist)
- Knowledge of regulatory requirements (EC DoC and NMPA highly desirable)
- Strong communication skills bringing stakeholders and 3rd party together to perform the clinical evaluation and management
- Good organizational and leadership qualities
- Proactive “getting things done” attitude
- Experience of liaising with medical opinion-leaders, specialist associations, funding bodies and politicians, ideally having a network within relevant specialist committees (highly desirable).
- Highly results-oriented with a growth mindset. Capable of presenting action to management and/or customers.
- Work experience within a multidisciplinary and multicultural environment (highly desirable).
Our global team:
We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
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Organization: Siemens Healthineers
Company: Siemens Shenzhen Magnetic Resonance Ltd.
Experience Level: Mid-level Professional
Job Type: Full-time