Associate Regulatory Affairs Manager

Responsibilities :

• The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products.
• This role will assist in managing regulatory projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements.
• The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.
• Assist 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.
• Help 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.
• Contribute to the maintenance of 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 :