Regulatory Affairs Specialist

21 hours ago


Hyderabad, Telangana, India Morulaa HealthTech Pvt. Ltd. Full time

Company Description

Morulaa HealthTech Pvt. Ltd. was founded to assist in the commercialization of bio-science technologies and the growth of healthcare companies. Based in Ohio and collaborating with Cleveland Clinic, University Hospitals, and Case Western Reserve University, Morulaa specializes in the Registration of Medical Devices and Distributor Selection in India. Our team identifies cutting-edge healthcare technologies globally to meet the demands of the Indian market. With over 100 years of business experience, we offer turnkey solutions with in-house regulatory and marketing teams that work seamlessly with clients to expedite the commercialization of healthcare products in India.

Role Description

This is a full-time, on-site role for a Regulatory Affairs Specialist located in Hyderabad. The Regulatory Affairs Specialist will be responsible for preparing and maintaining regulatory documentation, ensuring compliance with regulatory requirements, handling regulatory submissions, and managing overall regulatory affairs for medical devices with Indian CDSCO. The role involves collaborating with various teams to ensure timely regulatory approvals and effective product commercialization.

Qualifications

  • Minimum 2 years of experience in Regulatory Documentation and Regulatory Submissions skills
  • Understanding of Regulatory Requirements and Regulatory Compliance
  • Experience in managing Regulatory Affairs
  • Excellent analytical and problem-solving abilities
  • Strong organizational and project management skills
  • Effective communication skills, both written and verbal
  • Bachelor's degree in Life Sciences, Pharmacy, or a related field


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