Senior Regulatory Affairs Specialist - Onsite
Core
Senior Regulatory Affairs Specialist ensuring global regulatory compliance, data governance, and process excellence for the Neurovascular medical device portfolio.
Role type
Senior IC regulatory affairs specialist (medical devices)
Builds
Regulatory data integrity, compliance documentation, and cross-functional regulatory processes for stroke/neurovascular technologies
Domain
Medical devices / Neurovascular / Regulatory Affairs
Required skills
Regulatory data governance, standards assessments, regulatory change impact evaluation, cross-functional project coordination, medical device compliance, regulatory system implementation, UDI management, process improvement, data quality management, stakeholder coordination
Preferred skills
UDI and global device registration expertise, EUDAMED experience, regulatory information management systems, digital transformation and automation, AI-enabled regulatory initiatives, product lifecycle management
Technologies
Regulatory information management systems, EUDAMED, AI tools
Responsibilities
Manage regulatory data governance activities including data quality reviews and discrepancy resolution; Coordinate Unique Device Identification (UDI) activities and maintain accurate device registration data; Lead standards gap assessment processes and track required actions; Coordinate regulatory change assessments and evaluate impacts across products and regions; Lead or support cross-functional regulatory projects involving multiple products; Support implementation and validation of regulatory systems and digital solutions; Partner with stakeholders to implement process improvements and automation
Seniority
Senior, hands-on IC