SSMR MR Medical Officer 医学官
Siemens
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.
Your mission and responsibilities：
1. Release the MDR clinical evaluation of SSMR products for their release and launch to the EU market.a. Review & release of Clinical Evaluation Planb. Review gap analysis for new product clinical performance and advise project team on clinical evaluation requirements.c. Responsible for the evaluation of clinical data for new product clinical or clinical performance claims.d. Review for DOE (Demonstration of Equivalence)e. Review of Clinical Trial reportf. Review & release of Clinical Evaluation Report2. In a team with the CLC, drives the NMPA CER submission, bringing together stakeholders (e.g. phantom test, volunteer scans, Solution Owners, RA) and key contributors for a successful CER submission. 3. Along with the CLC own the NMPA clinical evaluation of SSMR products for their NMPA submission.a. Literature search review b. Owner of the gap analysisc. Review and release of the NMPA CER reportd. Support supplementary request requirements from NMPA.4. Medical assessment support for SSMR Product Risk Assessments:a. Risk level assessmentb. Benefit Risk ratio analysisc. Literature search strategy and analysis5. Responsible keeping up to date with latest regulatory body clinical evaluation requirements and standards (both MDR and NMPA). Drive continuous improvement and incorporate them into our processes and clinical lifecycle management.6. Collectively with the CLC, Responsible for the Clinical Evaluation and Clinical Lifecyle Management process according to Medical Device Regulation and NMPA regulations. Working closely with counterparts in Erlangen and quality department to establish a harmonized process.7. Active member of the global MR medical affairs team who represent and define the BL strategy for clinical lifecycle management. MO focusses on:a. Clinical benefit demonstration/assessment.b. Support in scheduling the clinical and PMCF resources to meet required timelines.8. Support for answering to audit questions and regulatory body deficiency letters or requests for additional information where required (both MDR & NMPA).
Your qualifications and experiences：
• Good level of English and Chinese language skills both spoken and written• Qualifications that provides necessary knowledge and experience in Patient Care and MRI Clinical Application. (e.g. MR technician, MR Application specialist, medical background)• Knowledge of regulatory requirements MDR and NMPA• Strong communication and teamwork skills. • 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.• Ability to work under pressure.• Sound knowledge about MR product portfolio
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. 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.
Our culture:
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.
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.
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.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
Your mission and responsibilities：
1. Release the MDR clinical evaluation of SSMR products for their release and launch to the EU market.a. Review & release of Clinical Evaluation Planb. Review gap analysis for new product clinical performance and advise project team on clinical evaluation requirements.c. Responsible for the evaluation of clinical data for new product clinical or clinical performance claims.d. Review for DOE (Demonstration of Equivalence)e. Review of Clinical Trial reportf. Review & release of Clinical Evaluation Report2. In a team with the CLC, drives the NMPA CER submission, bringing together stakeholders (e.g. phantom test, volunteer scans, Solution Owners, RA) and key contributors for a successful CER submission. 3. Along with the CLC own the NMPA clinical evaluation of SSMR products for their NMPA submission.a. Literature search review b. Owner of the gap analysisc. Review and release of the NMPA CER reportd. Support supplementary request requirements from NMPA.4. Medical assessment support for SSMR Product Risk Assessments:a. Risk level assessmentb. Benefit Risk ratio analysisc. Literature search strategy and analysis5. Responsible keeping up to date with latest regulatory body clinical evaluation requirements and standards (both MDR and NMPA). Drive continuous improvement and incorporate them into our processes and clinical lifecycle management.6. Collectively with the CLC, Responsible for the Clinical Evaluation and Clinical Lifecyle Management process according to Medical Device Regulation and NMPA regulations. Working closely with counterparts in Erlangen and quality department to establish a harmonized process.7. Active member of the global MR medical affairs team who represent and define the BL strategy for clinical lifecycle management. MO focusses on:a. Clinical benefit demonstration/assessment.b. Support in scheduling the clinical and PMCF resources to meet required timelines.8. Support for answering to audit questions and regulatory body deficiency letters or requests for additional information where required (both MDR & NMPA).
Your qualifications and experiences：
• Good level of English and Chinese language skills both spoken and written• Qualifications that provides necessary knowledge and experience in Patient Care and MRI Clinical Application. (e.g. MR technician, MR Application specialist, medical background)• Knowledge of regulatory requirements MDR and NMPA• Strong communication and teamwork skills. • 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.• Ability to work under pressure.• Sound knowledge about MR product portfolio
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. 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.
Our culture:
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.
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.
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.
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