SSMR MR RA Manager 法规部负责人
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.
Job Mission1. Consults the management (GM, Quality Director, Head of PLM, SCM) regarding current and future regulatory requirements and risks in medical device/pressure vessel.2. Drives together with the SSMR management for regulatory requirement compliance of SSMR.3. Manage RA department, as the mentor and give fully support for all department members.4. Have the authority and is obliged to stop any processes and projects in cases where the corresponding regulatory requirements are not fulfilled.
Responsibilities1. Monitor and interpret related regulatory issues and trends that will impact the business of the BL.2. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.3. Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.4. Interface with government agencies, notify bodies and industry associations to access the impact and implementation of required company compliance with all regulations, laws and policies that affect the company products.5. Develop regulatory strategies and implementation plans for the preparation and submission of new products.6. Direct the preparation and submission of regulatory agency applications, reports, or correspondence.7. The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date8. Establish regulatory priorities or budgets and allocate resources and workloads.9. Provide regulatory guidance to departments or department project teams regarding design, development, evaluation, or marketing of products.10. Manage activities such as regulatory agency inspections.11. Provide responses to regulatory agencies regarding product information or issues.12. Coach, mentor and develop staff, including overseeing new employee onboarding and provide career development planning and opportunities.13. Ensure that the personnel of the department have received relevant training and mastered relevant theoretical knowledge and practical operation skills. Requirements1. At least 5 years working experience in the regulatory affairs or similar QMS relevant of medical device;2. Working experience at least 2 years in foreign company in the condition that English is the working language.
Our global team:
We are a team of 71,000 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.
Job Mission1. Consults the management (GM, Quality Director, Head of PLM, SCM) regarding current and future regulatory requirements and risks in medical device/pressure vessel.2. Drives together with the SSMR management for regulatory requirement compliance of SSMR.3. Manage RA department, as the mentor and give fully support for all department members.4. Have the authority and is obliged to stop any processes and projects in cases where the corresponding regulatory requirements are not fulfilled.
Responsibilities1. Monitor and interpret related regulatory issues and trends that will impact the business of the BL.2. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.3. Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.4. Interface with government agencies, notify bodies and industry associations to access the impact and implementation of required company compliance with all regulations, laws and policies that affect the company products.5. Develop regulatory strategies and implementation plans for the preparation and submission of new products.6. Direct the preparation and submission of regulatory agency applications, reports, or correspondence.7. The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date8. Establish regulatory priorities or budgets and allocate resources and workloads.9. Provide regulatory guidance to departments or department project teams regarding design, development, evaluation, or marketing of products.10. Manage activities such as regulatory agency inspections.11. Provide responses to regulatory agencies regarding product information or issues.12. Coach, mentor and develop staff, including overseeing new employee onboarding and provide career development planning and opportunities.13. Ensure that the personnel of the department have received relevant training and mastered relevant theoretical knowledge and practical operation skills. Requirements1. At least 5 years working experience in the regulatory affairs or similar QMS relevant of medical device;2. Working experience at least 2 years in foreign company in the condition that English is the working language.
Our global team:
We are a team of 71,000 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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