Sr Regulatory Affairs Specialist

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.

Analyzes the requirements and prepares product related regulatory submissions.

• Develops and implement quality guidelines and work instructions relevant to ensure regulatory compliance.
• Identifies, analyzes and implements country specific requirements necessary for product related submissions.
• Plans, analyze and prepares product related submissions with Siemens internal (e.g. Branch Countries) or external organizations according to regulatory requirements.
• Performs regulatory projects or acts as a member of the project steering group.
• Submits required documentation/information to local authorities, 3rd party vendor (distributor / consultant) or Siemens internal.
• Facilitate and manages monthly meetings to provide updates to relevant stakeholders on the regulatory activities in the region.
• Oversee budget management for IS QT APJ region, ensuring effective financial control and resource allocations.
• Initiates corrective actions and escalate issues when deviations are identified.
• Ensures creation of adequate documentation for audits/inspections.
• Performs training within the organization in country specific regulatory requirements, if applicable.
• Performs review of promotional material for regulatory compliance according to country specific requirements.
• May represent the company in industry associations (Lobbying), if applicable.

Who we are: We are a team of more than 73,000 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.

To find out more about Healthineers’ specific businesses, please visit our company page here.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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