"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

Responsibilities

  • 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.

Qualifications

  • 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.

Skills

  • 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.

Keywords: Pharma, Siemens Healthineers, Regulatory Affairs, Recruitment, Apply Online. Pharma Siemens Healthineers Regulatory Affairs Recruitment, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.

LEAVE A REPLY

Please enter your comment!
Please enter your name here