Sr Regulatory Affairs Specialist Job in
- Kpr sugar apperals
- 3 to 7 Yrs
- Other Andhra Pradesh
- 9 months ago
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Job Description
- 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. 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.,
Employement Category:
Employement Type: Full timeIndustry: Medical / HealthcareRole Category: Not SpecifiedFunctional Area: Not SpecifiedRole/Responsibilies: Sr Regulatory Affairs Specialist Job inContact Details:
Company: Siemens HealthineersLocation(s): Other Andhra Pradesh+ View Contact
Keyskills: Regulatory Submissions Budget Management Corrective Actions Training
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