Regulatory Affairs Specialist
Regulatory Affairs Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Key Responsibilities:
-
Regulatory Submissions:
-
Prepare and submit dossiers for product approvals to regulatory authorities (CDSCO CE USFDA etc.).
-
Manage correspondence and follow-ups with regulatory bodies.
-
-
Compliance Management:
-
Ensure compliance with ISO 13485 MDR and other global regulatory standards.
-
Monitor and implement regulatory changes across processes and documentation.
-
-
Documentation and Technical Files:
-
Maintain and update technical files design dossiers and product labeling.
-
Review product IFUs promotional materials and specifications for regulatory compliance.
-
-
Audit and Inspection Support:
-
Prepare for and support internal and external audits.
-
Assist in resolving non-conformities and ensuring timely corrective actions.
-
-
Cross-functional Coordination:
-
Collaborate with QA QC and production teams to ensure regulatory compliance.
-
Provide regulatory input for new product development and modifications.
-
-
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.
Employment Type
Full Time
