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 Senior Manager (f/m/d) Post-Market Surveillance to support our Business Areas, Business Lines, Business Horizontals and Technology Excellent Units in close cooperation with our country organizations in the application-oriented interpretation and implementation of global post-market requirements for in-vivo and in-vitro diagnostic medical devices.
Choose the best place for your work – Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.
Your tasks and responsibilities:
You independently advise our employees on achieving and maintaining regulatory compliance in post-market topics for in-vivo and in-vitro diagnostic medical devicesYou provide initiative-taking, hands-on support to our manufacturing units and country organizations in analyzing and implementing of international regulatory post-market requirementsYou function as a primary point of contact for manufacturing units and country organizations regarding post-market surveillance requirementsYou communicate new or updated post-market surveillance requirements to the global post-market community within Siemens HealthineersYou actively engage in national and international industry associations focused on post-market topics for in-vivo and in-vitro diagnostic medical devicesCollaborating with subject matter experts from manufacturing units and country organizations, you identify potential weaknesses and opportunities for improvement in post-market surveillance processes, develop solutions, implement them, and optimize interfaces and communication channelsYou lead and/or participate in international post-market expert teams, task force teams, and projects to deliver practical and compliant solutions in this areaYou create quality documents for post-market surveillance topics in English.You are responsible for creating and independently delivering worldwide training sessions on post-market surveillance topics for employees and external institutions (e.g., customers, regulatory authorities), including the development of training materials
To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services
Your qualifications and experience:
You hold a university degree in science or technology, complemented by many years of relevant professional experience in the post-market field for in-vivo and in-vitro diagnostic medical devicesYou have in-depth knowledge of global regulatory post-market and vigilance requirements, including complaint handling, update processes, adverse event reporting, and field safety corrective action reporting for in-vivo and in-vitro diagnostic medical devicesYou are not only well-versed in post-market and vigilance processes for in-vivo and/or in-vitro diagnostic medical devices but also ideally familiar with service processes related to customer care and supportYou are actively engaged in manufacturer associations (e.g., COCIR, MEDTech Europe, ZVEI) regarding post-market issuesYou possess strong knowledge of European Medical Device Regulations 2017/745 and 2017/746, as well as U.S. post-market regulatory requirements, such as 21 CFR 803 and 21 CFR 806Familiarity with post-market requirements in other global jurisdictions, such as China, Brazil, and India, is an advantageIdeally, you have experience with Lean methodologies (e.g., A3, Value Stream Analysis) and have actively applied them in your workYou possess solid knowledge of MS Office applications, and you have experience working with SmartSolve applications
Your attributes and skills:
You demonstrate effective communication skills in both written and spoken German and English at a business-fluent levelYou are enthusiastic about driving digitalization and automation of post-market processes.You are willing to travel globally (max. 20%).You work independently, in a structured and purposeful manner. You are assertive and adept at leveraging your intercultural experience to navigate diverse cultures and personalities within international teamsYour strengths include entrepreneurial thinking and action, motivational leadership, analytical acumen, and an initiative-taking mindset. You also exhibit resilience, adaptability, and flexibility
Our global team:
Siemens Healthineers is a leading global medical technology company. 72,000 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:
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 https://www.siemens-healthineers.com/de/careers
As an equal opportunity employer, we welcome 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 Simone Morgenstern.
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To all recruitment agencies:
Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.
Siemens Healthineers Germany was awarded the Great Place to Work® certificate.