Company: Adiuvo Diagnostics Private Limited
About Us:
Adiuvo Diagnostics Private Limited, an ISO 13485:2016 QMS company, is a leader in developing innovative medical devices. We are seeking a Regulatory Head to oversee end-to-end regulatory affairs, ensuring compliance with US FDA, EU MDR, and Indian CDSCO requirements.
Key Responsibilities:
- Regulatory Strategy: Develop and implement regulatory strategies aligned with US FDA, EU MDR, and CDSCO.
- Compliance: Ensure all our medical devices meet US FDA, EU MDR, and CDSCO standards.
- Documentation: Manage regulatory documentation, submissions, and audits.
- Cross-functional Collaboration: Collaborate with internal teams for compliance.
- CDSCO Clearance: Ensure all our medical devices meet CDSCO clearance process in India.
Qualifications:
- Bachelor's degree in relevant field.
- years of medical device regulatory experience.
- Strong knowledge of US FDA, EU MDR, and CDSCO regulations.
- ISO 13485:2016 QMS certification a plus.
- Excellent communication and leadership skills.
