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About Company

The Indian Institute of Science (IISc) is seeking a Regulatory and Clinical Affairs Executive to join our team. This role requires a commitment of at least one year and involves working closely with the Engineering team through the product development process and design activities. The position is crucial for guiding the organization in preparing regulatory submissions and documentation, ensuring compliance with national and international standards.

Position Name :

Regulatory and Clinical Affairs Executive

Organization :

Indian Institute of Science

Qualification:

Bachelor’s/Master’s Degree

Experience:

1 to 2 Years

Salary:

CTC: 7 LPA

Location:

Bengaluru

Essential Skills Required:

  • A minimum of 1 year of Class B (Class II) or above medical device quality and regulatory experience.
  • Excellent analytical and critical thinking skills.
  • Prior experience in small organizations or startups and fast-paced environments.
  • Completed at least one medical device licensing application in India. Overseas registration experience is desirable.
  • Ability to apply ethical standards to business and regulatory affairs.
  • Knowledge of the IEC 60601 suite of standards.
  • Knowledge of requirements for SaMD and embedded software regulations is highly preferred.
  • Ability to quickly learn third-party test requirements such as IEC product testing, biocompatibility testing, and sterilization.
  • Strong understanding of Indian, EU, and FDA regulatory processes.
  • Demonstrated experience in risk management activities per ISO 14971.
  • ISO 13485 internal/lead auditor certification is preferred.
  • Strong verbal and written communication skills in English. Knowledge of Hindi and Kannada is a plus.
  • Able to work independently and handle multiple tasks and changing priorities.

Key Responsibilities:

  • Guide the organization in preparing regulatory submissions and documentation, including design files, technical files, clinical trial permissions, and license applications.
  • Lead the pathway to market Class C (Class IIb) devices by successful applications with national regulatory bodies.
  • Work with consultants to develop a quality management system as per ISO 13485 standards.
  • Provide technical review of reports for regulatory submissions.
  • Identify and interpret relevant guidance documents, international standards, or consensus documents.
  • Support clinical affairs by drafting, reviewing, and amending protocols and clinical evaluation reports.
  • Author or revise Standard Operating Procedures (SOPs) to maintain quality management systems.
  • Prepare and review risk management files, including hazard analysis and FMEA.
  • Maintain a current knowledge base of existing and emerging regulations and standards.
  • Review or approve product labeling, specification sheets, or test methods for compliance.
  • Support and improve the company’s quality systems by fostering a quality culture and providing ongoing education on compliance activities.

Application Link