"Pharma Siemens Healthineers Recruitment: Apply Now for Regulatory Affairs Position!"

Pharma Siemens Healthineers Regulatory Affairs Recruitment, Apply Online

Siemens Healthineers is a leading company in the healthcare industry. We are currently hiring for the position of Regulatory Affairs Professional in Vadodara, Gujarat, India.

Job ID: 400966

Organization: Siemens Healthineers

Job Family: Quality Management

Experience Level: Experienced Professional

Full Time / Part Time: Full-time

Remote vs Office: Office/Site Only

Contract Type: Permanent


  • Regulatory Compliance:
  • Ensure adherence to regulatory requirements for In Vitro Diagnostics in accordance with MDR 2017.
  • Stay updated on regulatory changes and effectively communicate their impact on the organization.
  • Geographical Oversight:
  • Responsible for regulatory affairs activities in India, with extended coverage to neighboring countries and ASEAN.
  • Navigate regulatory landscapes to facilitate product registrations and approvals.
  • Certification and Qualification:
  • Knowledgeable in the acquisition of CE Marking, USFDA approval, and WHO qualification for IVD products.
  • Facilitate and oversee the regulatory processes for obtaining necessary certifications.
  • Liaison and Collaboration:
  • Build and maintain effective relationships with regulatory bodies, including but not limited to Gujarat FDCA, CDSCO, ICMR, and NIB.
  • Collaborate with internal teams to ensure regulatory compliance throughout the product life cycle.
  • Documentation and Submission:
  • Prepare and submit regulatory documents, ensuring accuracy and completeness.
  • Manage regulatory submissions and responses to inquiries from regulatory agencies.
  • Risk Management:
  • Identify and assess regulatory risks associated with IVD products.
  • Develop and implement strategies to mitigate regulatory risks.
  • Training and Awareness:
  • Conduct training sessions for internal teams to enhance regulatory awareness.
  • Keep the organization informed about changes in regulations and their implications.


  • Bachelor’s or Master’s degree in a relevant field (Life Sciences, Biotech, Pharmacy or Regulatory Affairs, etc.).
  • Minimum 6-8 years of experience in Regulatory Affairs, with a focus on In Vitro Diagnostics for the last 3 years.
  • Thorough knowledge of MDR 2017 and other relevant regulations.
  • Experience in acquiring CE Marking, USFDA approval, and WHO qualification will be highly preferred.


  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Detail-oriented with a focus on accuracy in documentation.
  • Ability to work collaboratively in a cross-functional team environment.

To apply for this position, please visit the original notification.

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