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

WhatsApp D. Pharma Group Join Now
Telegram D. Pharma Group Join Now
Telegram Group Latest Pharma Jobs Join Now
Telegram B. Pharma Group Join Now
Telegram Medicine Update Group Join Now
WhatsApp B. Pharma/ GPAT Channel Join Now

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
Quality Management
Siemens Healthineers
Job ID
Apply Online Click Here


MORE JOBS: Research Opportunity for M. Pharma/ MS Pharma/ M. Sc as a Junior Research Fellow at BIT Mesra – Apply Now

<<<<<<<<<<<<JOIN US>>>>>>>>>>>>>>>>

Subscribe our PHARMACY INDIA Youtube Channel for more Pharma Updates Click Here
Follow us on Instagram Click Here
Download PHARMACY INDIA MOBILE APP from Google Play Store  Click Here
Follow us on LinkedIn Click Here


Please enter your comment!
Please enter your name here