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 dir...
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