Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
Job Mission: Ensure timely and high-quality registration of in vitro diagnostic medical devices in the Russian Federation, in compliance with applicable national and international regulatory requirements.
Responsibilities:Register new products, including the direct preparation of dossier documents, overseeing the process at all stages, and coordinating documentation with internal customers (including manufacturer representatives) and external partners.Make changes to registration certificates and dossier documents.Evaluate and process notifications of product changes from manufacturers; determine the strategy for further actions to implement changes if necessary.Maintain product compliance with current regulatory requirements.Obtain permits and licenses.Monitor and analyze changes in the regulatory framework of the Russian Federation and the Eurasian Economic Union (EAEU).Monitor the safety of medical devices and interact with regulatory authorities.Participate in the work of professional associations and external working groups.Archive and maintain registration documentation (both paper and electronic).Interact with other departments when preparing responses, requests, and justifications to external organizations.
Requirements:Relevant work experience of at least 3 years.Experience working in foreign companies is an advantage.Proficiency in English at an Upper Intermediate level or higher (both spoken and written).Attention to detail, strong analytical skills, and result-oriented.
Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
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. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities.
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.