Senior Regulatory Supervisor

Job Description :

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will involve working closely with cross-functional teams to ensure compliance with regulatory standards, preparing regulatory submissions, and providing strategic regulatory guidance for new and existing products.

Key Responsibilities :

• Lead the preparation, submission, and management of FDA 510(k) premarket notifications for medical devices.
• Prepare and review regulatory documentation to ensure compliance with FDA regulations and standards.
• Advise product development teams on regulatory requirements and strategy throughout the product lifecycle.
• Maintain up-to-date knowledge of FDA regulations, guidance documents, and industry best practices.
• Interface with FDA and other regulatory authorities to respond to inquiries and resolve regulatory issues.
• Ensure timely submission of regulatory filings, meeting project deadlines and milestones.
• Support internal audits and inspections related to regulatory compliance.
• Review labeling and promotional materials to ensure compliance with regulatory requirements.
• Develop and implement strategies for regulatory approvals in international markets, as needed.

Qualifications :

Preferred :

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Skills Required

regulatory documentation