24 Sep
|
Siemens Healthineers
|
Maharashtra
24 Sep
Siemens Healthineers
Maharashtra
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring setting 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.
Prepare Radiation Safety-related documentation, including the organization and achieving of Radiation Safety brochures and associated records.
Provide technical support to localized regulatory specialists as well as UDI project through data processing, verification, and coordination activities that include processing project-related data according to defined requirements, reviewing information for completeness and accuracy, coordinating with stakeholders to rectify discrepancies, issues requiring clarification, etc.
Regulatory audit and related invoice processing and coordination with finance teams and the appropriate teams when clarification or correction is required. Tracking regulatory invoice-related activities and ensuring timely processing. Supporting accurate documentation and maintaining appropriate records.
Coordinate leadership events and meetings including event schedules and ensuring required arrangements are completed, providing logistics coordination support during events and leadership business travel and expense management.
Provide data collection, PowerPoint presentation support for QT communications, Town Halls, leadership meetings, and important business, Quality, Regulatory, compliance, and leadership activities.
This role requires working across multiple functions and time zones and interacting with different levels of senior leaders in the organization.
- Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
- Identifies, analyzes and implements country specific requirements necessary for product related submissions.
- Plans 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 or Siemens internal.
- Initiates and escalates necessary activities if 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 72,000 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.
Data Privacy: 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. We ask instead that you create a profile where you can upload your CV. Setting up a profile also lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.
Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location.
Siemens
Healthineers is not responsible for any fees related to unsolicited resumes. As an equal opportunity employer, we welcome applications from individuals with disabilities.
📌 Regulatory Affairs Professional (Maharashtra)
🏢 Siemens Healthineers
📍 Maharashtra