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Utilizes technical device knowledge, regulatory expertise and global regulatory lessons learned to shape EEA regulatory best practices, drive internal consistency and influence effective change management
Provides technical, strategic and tactical regulatory guidance to product teams by defining and optimizing EEA regulatory strategies pertaining to the development, registration, commercialization and life cycle management of assigned products
Informs strategy for device-related and combination product aspects of EEA regulatory submissions (e.g., CE-marking, Notified Body Opinions, Variations, etc.)
Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labeling, etc) to ensure effective strategies are developed and project execution is on target
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Demonstrated track record of successful interactions with Notified Bodies and other global health authorities, including device submissions. EMA interactions and submissions, specifically related to Combination Products and Drug-Delivery experience (i.e., Notified Body Opinions, etc.) is preferred
Dublin-Baggot Street, Ireland
Base Salary Range:
€116,800.00 - €160,600.00
For information about our benefits, please click here.
Employee
Regular
Full time
