Associate Regulatory Affairs Manager

Responsibilities

• Support the development, review, and submission of regulatory documents for medical device and IVD products.
• Manage regulatory projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements.
• Work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.
• Aid in the preparation, review, and submission of regulatory documentation for new products, product changes, and ongoing compliance.
• Support the regulatory submission process for 510(k), Technical Files, and other regulatory filings.
• Provide regulatory guidance to cross-functional teams during product development and post-market activities under the direction of senior management.
• Track and manage submission timelines, regulatory project plans, and documentation.
• Stay informed on changes in FDA, ISO 13485, IVDR, and other global regulations, communicating relevant updates to the team.
• Conduct regulatory assessments for product modifications and assist in defining appropriate submission strategies.
• Participate in internal and external audits, inspections, and regulatory agency communications as assigned.
• Maintain regulatory files and submission records in accordance with internal procedures and regulations.
• May provide oversight and mentorship to junior staff or specialists on assigned projects.

Requirements

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
• 46 years of regulatory affairs experience in the medical device or IVD industry.
• Experience supporting or managing 510(k) submissions and regulatory filings.
• Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and international medical device regulations.
• Strong organizational, document management, and project coordination skills.
• Excellent communication, problem-solving, and cross-functional collaboration abilities.
• Detail-oriented with the ability to manage multiple regulatory projects and priorities.
• Proficient in Microsoft Office and regulatory document management systems.
• Ability to work independently and proactively while seeking guidance for complex issues.