Siemens Healthcare Private Limited is hiring Regulatory Affairs Analyst – B. Pharma/ M. Pharma/ Pharma D can Apply

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Siemens Healthcare Private Limited is currently seeking talented individuals for the role of Regulatory Affairs Analyst in Bangalore. If you have a B. Pharma, M. Pharma, or Pharma D degree, this is a fantastic opportunity to join a leading global healthcare company and advance your career. Discover how you can contribute to regulatory compliance and ensure the highest standards of healthcare products. Apply today and be part of a team dedicated to innovation and excellence in the healthcare industry.

Position: Regulatory Affairs Analyst

Qualifications Regulatory Affairs Analyst at Siemens Healthineers

  • You have successfully completed a course of studies in a technical or clinical field, preferably in engineering, medicine, medical engineering or (medical) informatics
  • You have 3-5 years of experience in regulatory affairs for Software as Medical Device, SaaS, and/or cloud deployments
  • You have a sound knowledge of international laws, standards and regulations for licensing medical devices, and of the business processes of medical device manufacturers (e.g. MDD/MDR, 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971)
  • Your profile also includes a knowledge of regulatory requirements for the clinical evaluation of software for medical devices
  • Experience in process or quality management would be an advantage

Your Attributes And Skills for Regulatory Affairs Analyst at Siemens Healthineers

  • You are business-fluent in English, enabling you to operate successfully in our international context; knowledge of German would be an advantage
  • Your personal qualities include a professional approach, skills in planning and organization, and cross-cultural experience
  • You also have team and communication skills, initiative, and a structured, target-oriented way of working
  • You champion the success of Siemens Healthineers with drive and passion

Roles and Responsibilities Regulatory Affairs Analyst at Siemens Healthineers

  • Ensure the medical device products comply with the regulations of the regions where it is planned to be marketed and sold.
  • Maintaining a good understanding of new and existing regulations, standards and guidances that may impact their organization’s products and processes.
  • Collect, collate and evaluate product specific information in order to create and update the dossiers that must be submitted for new product licenses and license renewals.
  • Prepare submissions for regulatory registration and renewals
  • Maintaining data and files on country registrations for future reference, particularly in the event of an audit by a regulatory agency
  • Preparing for and supporting internal, regulatory, and third-party audits as necessary
  • Collaborate with the project teams and explaining regulatory requirements, procedures, and policies to all employees and stakeholders as necessary.
  • Able to work in cross functional teams with good communication & interpersonal skills
Location Bangalore
Job Type Full Time
Category
Quality Management
Company
Siemens Healthineers
Job ID
421504
Apply Online Click Here

 

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