
Expert Regulatory Compliance Specialist
2 days ago
Regulatory Affairs Expert
We are seeking a seasoned professional to spearhead our regulatory affairs efforts. As a key member of our team, you will be responsible for ensuring compliance with international, federal, and local regulations across pharmaceuticals and medical devices.
- Key Responsibilities:
- Develop and implement regulatory strategies to support new product development and lifecycle management.
- Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Collaborate with cross-functional teams to integrate regulatory requirements into product development.
- Manage regulatory documentation archives and maintain compliance records for audits and inspections.
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