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. Sound interesting? Then come and join our global team as Regulatory Affairs Manager.
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.
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. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitious professional, looking for the next step in their career.
As a Regulatory Affairs Manager, you will be responsible for:
• In your activities you will demonstrate leadership capabilities to manage and guide a group of regulatory affairs specialists to provide registration support for the Atellica Solution product line.
• You will manage and guide regulatory affairs specialist supporting instrument development projects which includes transitioning our assay menu to new platforms.
• You will take part at the knowledge exchange with our regulatory affairs teams to improve and further develop or refine processes
This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
• Managing group of RA specialists in the US and India, and providing regulatory guidance
• Strong knowledge of analyzers, workflow and solution products and applicable regulations for such products
• Strong knowledge of both immunoassay and chemistry assay products.
• You have very good presentation skills and you show team orientation and communication skills
• Ensure cross-functional collaboration and cooperation
• Communicate effectively to key stakeholders at all levels
Required skills to have for the success of this role
• Bachelor's degree in Biology/Chemistry/Engineering or equivalent experience required. Master's degree preferred
• Proven leadership experience in managing group of specialists preferred
• Strong listening, verbal and written communication skills
• Must be able to work independently, be self-motivating and act as a change agent
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
This role can be primarily home based, with occasional travel to a business site for meetings, as needed.
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date, except where prohibited by state law. Accommodations may be requested for certain medical or religious reasons. If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer. Details on how to submit approval will be provided by your recruiter. An accommodation approval must be confirmed prior to your start date. A start date cannot be confirmed until the accommodation has been reviewed. An accommodation is based on your role. If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new role
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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