Regulatory Compliance Expert
1 day ago
Our organization seeks a seasoned Regulatory Affairs professional with extensive expertise in pharmaceutical and medical device regulatory compliance.
The ideal candidate will possess a deep understanding of international, federal, and local regulatory requirements across these industries.
Key Responsibilities:- Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
- Ensure adherence to regulatory standards by developing and maintaining effective strategies for new product development and lifecycle management.
- Interact with regulatory authorities during product submissions, inspections, and audits, fostering strong relationships and communicating complex information effectively.
- Review labeling, promotional materials, and product packaging for compliance with applicable regulations, providing actionable feedback and recommendations.
- Maintain up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance and adaptability.
- Support quality systems aligned with ISO 13485 and ICH standards, promoting a culture of excellence and continuous improvement.
- Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration.
- Excellent communication, problem-solving, and analytical skills.
- Ability to work independently in a remote setting with minimal supervision.
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