Job Description
What will you do:
Supports assessment of regulatory requirements, stakeholder expectations, and emerging regulatory trends, and highlights potential impacts to regulatory teams.Contributes to execution of regulatory strategies by supporting global, regional, and multi-country submission activities
Assists in identifying regulatory pathways for product changes and supports documentation required for submissions. Supports evaluation of regulatory requirements for product lifecycle activities, including design, labeling, and manufacturing changes
Coordinates preparation, compilation, and submission of regulatory dossiers (e.g., FDA 510(k), EU MDR Technical Files, emerging market submissions).Ensures completeness, accuracy, and compliance of submission documentation in alignment with regulatory requirements
Maintains and updates regulatory information management systems (RIM) to track submissions, appr...