Opportunity Description
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 dir...
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