Senior Regulatory Specialist - Canada (French/English Bilingual Preferred)
Core
Senior Regulatory Specialist managing Health Canada medical device regulatory submissions, license portfolios, and compliance strategies for innovative medical devices.
Role type
Senior Regulatory Specialist (Medical Devices)
Builds
Regulatory submissions and compliance strategies for medical device products
Domain
Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Medical device regulations (ISO 13485, Design Controls), Health Canada submission expertise, regulatory license portfolio management, ERP/RIM system data maintenance, audit/inspection representation, stakeholder alignment, continuous improvement initiatives
Preferred skills
Bilingual (French/English), strategic leadership, project management
Technologies
ERP, ship control, RIM systems
Responsibilities
Develop and implement communication strategies with partners; Align regulatory strategies with commercial revenue plans; Manage regulatory license portfolios for responsible countries; Lead integrated regulatory process improvement initiatives; Support due diligence for new acquisitions; Represent Regulatory Affairs in audits/inspections; Train stakeholders on regulatory requirements and tools
Seniority
Senior, hands-on IC
