
Global Regulatory Compliance Specialist
3 days ago
Regulatory Affairs Expert Role
Job Summary:
We are seeking a seasoned Regulatory Affairs expert with extensive knowledge of pharmaceutical and medical device regulatory compliance.
The ideal candidate will have expertise in preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations.
Key Responsibilities:
- Developed and maintained regulatory strategies for product lifecycle management, supporting new product development and commercialization.
- Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
- Interacted with regulatory authorities during product submissions, inspections, and audits.
- Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations.
- Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.
- Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.
- Collaborated with cross-functional teams to integrate regulatory requirements into product development.
- Managed regulatory documentation archives and maintained compliance records for audits and inspections.
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