Regulatory Affairs Specialist (Hiring)

src="images/6.png" alt="">3-4 years in Medical Device Regulatory Affairs Full-Time

Key Responsibilities:

1. Regulatory Submissions:
   • Prepare and submit dossiers for product approvals to regulatory authorities (CDSCO, CE, USFDA, etc.).
   • Manage correspondence and follow-ups with regulatory bodies.
2. Compliance Management:
   • Ensure compliance with ISO 13485, MDR, and other global regulatory standards.
   • Monitor and implement regulatory changes across processes and documentation.
3. Documentation and Technical Files:
   • Maintain and update technical files, design dossiers, and product labeling.
   • Review product IFUs, promotional materials, and specifications for regulatory compliance.
4. Audit and Inspection Support:
   • Prepare for and support internal and external audits.
   • Assist in resolving non-conformities and ensuring timely corrective actions.
5. Cross-functional Coordination:
   • Collaborate with QA, QC, and production teams to ensure regulatory compliance.
   • Provide regulatory input for new product development and modifications.
6. Regulatory Intelligence:
   • Stay updated on global regulatory changes and provide impact assessments for ongoing projects.
   • Ensure timely updates to quality systems and documentation.

Skills Qualifications:

• Degree in pharmacy, life sciences, or related field.
• Proven experience in regulatory submissions and compliance for medical devices or pharmaceuticals.
• Strong organizational, analytical, and communication skills.