Senior Regulatory Affairs Manager
Core
Lead global regulatory strategy and team management for medical devices in continence care, ensuring compliance across the full product lifecycle.
Role type
Senior Regulatory Affairs Manager (Medical Devices)
Builds
Compliant medical device products for the Personal Care category
Domain
Medical Devices / Continence Care / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, team leadership, global matrix organization management, compliance management, stakeholder collaboration, process improvement, project management, European and US medical device regulations expertise
Preferred skills
Scientific or technical degree background, experience in innovation and change projects
Technologies
None stated
Responsibilities
Lead and coach a team of regulatory managers and specialists; Define and drive regulatory strategies from early development through lifecycle management; Act as the regulatory business partner advising on risks and opportunities; Provide regulatory guidance in innovation and change projects; Ensure products and documentation remain compliant with global regulations; Coordinate with regional teams and external stakeholders for market access; Drive harmonization of regulatory ways of working
Seniority
Senior, hands-on IC with leadership responsibilities