Senior RA Specialist

**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, approvals, and renewals. Supports change control processes by c...