- Develop and implement regulatory strategies for the registration and approval of medical devices in India.
- Prepare and submit regulatory filings, including applications, notifications, and registrations, to regulatory authorities such as CDSCO and BIS.
- Stay up-to-date with changes in regulatory requirements, guidelines, and standards related to medical devices in India.
- Coordinate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure regulatory compliance throughout the product lifecycle.
- Review and approve labeling, packaging, and promotional materials to ensure compliance with regulatory requirements.
- Participate in regulatory audits and inspections, and implement corrective and preventive actions as necessary.
- Provide regulatory guidance and support to internal teams and external stakeholders.
- Maintain regulatory documentation and records in accordance with company policies and regulatory requirements.
- Conduct regulatory training sessions for employees to enhance awareness and understanding of regulatory compliance.
- Contribute to continuous improvement initiatives related to regulatory processes and systems.
Qualifications:
- Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Engineering).
- Minimum of 2 years of experience in regulatory affairs within the medical device industry, with a focus on Indian regulatory requirements.
- Strong understanding of Indian regulatory frameworks, including CDSCO regulations, BIS standards, and ISO 13485.
- Experience preparing and submitting regulatory filings for medical devices in India.
- Excellent communication, organization, and problem-solving skills.
- Ability to work effectively in a cross-functional team environment and manage multiple priorities.
- Certification in regulatory affairs (e.g., RAC) is a plus.
Experience Required:
- Medical Device Regulatory: 2 years (Required)
- ISO 13485 Documentation: 1 year (Required)