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.
