Multinational medical device company is looking for an experienced Regulatory compliance specialist to ensure compliance with all local and international regulatory requirements, including FDA (U.S.), Egyptian Drug Authority (EDA), ANVISA (Brazil), LATAM (Latin American), etc. and other relevant markets. The role involves managing legal manufacturing agreements, private/white label partnerships, and direct manufacturing contracts while ensuring proper product registrations and compliance documentation.

 Reports To: Compliance Manager

Key Responsibilities:

Regulatory Submissions & Compliance:

• Prepare, review, and submit regulatory filings for the FDA (510k, PMA, etc.), EDA (Egyptian Drug Authority), ANVISA (Brazil), LATAM registrations, and other global markets.
• Ensure compliance with ISO 13485, MDR (EU), and other applicable standards.
• Maintain up-to-date knowledge of medical device regulations in key markets.

Manufacturing & Labeling Compliance:

• Oversee compliance in Legal Manufacturing, Private Label, White Label, and Direct Manufacturing Agreements. o Ensure proper documentation for OEM/contract manufacturing partnerships.
• Review and approve labeling, IFUs (Instructions for Use), and packaging for regulatory compliance.
• Ensure proper post-market surveillance (PMS) and vigilance reporting.

Cross-Functional Collaboration:

• Work with R&D, Quality, and Production teams to ensure compliance in product development.
• To Liaise with suppliers, distributors, and regulatory authorities for approvals.