Siemens Healthineers
Website:
siemens-healthineers.com
Company:
https://www.linkedin.com/company/siemens-healthineers
Seniority: Mid-Senior level
Industries: Medical Equipment Manufacturing, Hospitals and Health Care, and Biotechnology Research
Job details:
Your tasks and responsibilities:
- Analyzing global requirements for product registration and support the creating, shaping, and maintaining process framework for the implementation of the necessary activities in the pre- and post-market phases
- Planning and preparing product related medical device submissions with Siemens Healthineers internal regional units according to country specific regulatory requirements and maintaining of licensed products (e.g., for India, Latin America, Asia)
- Take responsibility for component registrations following respective standards such as BIS, CCC and NOM of relevant parts of the Siemens Healthineers AT products
- You will provide professional advice to and actively support internal departments, such as product management, (clinical) marketing- and product development in implementation and fulfillment of global regulatory requirements (laws, guidelines, regulations) for registration of medical devices
- Following a Clinical and Product Lifecycle Management approach together with the interfacing departments, to ensure optimal utilization of synergies, operational efficiency, and regulatory compliance essential for the major markets
- Supporting the creation of clinical evaluation reports for the EU and China ensuring compliance with applicable regulations and timely provision to authorities
Your qualifications and experience:
- You have a university degree in medical engineering, or a comparable field of study with relevant knowledge of imaging procedures (e.g., radiography, fluoroscopy) and clinical interventional procedures
- You have knowledge of the pertinent regulatory frameworks of the EU, China, India, and Latin America. Experience regarding USA registrations would be beneficial
- You have professional experience in the regulatory affairs functions or in comparable positions in the medical device industry, and you are very familiar with relevant interfacing processes, such as product risk management, post-market surveillance, and product lifecycle management
Your attributes and skills:
- You show a collaborative, inspiring working stile, and you can accommodate different personalities in a functional team
- You have excellent written and spoken English communication skills
- You are a great communicator, collaborative, inspiring, and able to accommodate different personalities in a functional team
- You are experienced in working in a demanding environment, and you pursue the aligned strategic targets by prioritization, consolidation, and smart decision making
- We win together: you are a team player; you follow the Siemens Healthineers goals with dedication and passion for the job
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