Frida

Compliance

• Manage the development and implementation of regulatory strategies and plans to support the timely introduction of new products and the preparation/review of international regulatory submission(s) (EU MDR Tech File, Health Canada submission, Saudi FDA, etc)
• Represent international regulatory interests on cross-functional project team for new and existing products
• Review and approve labeling requirements for global market(s); translation material, claims review, IFU, etc.
• Evaluate change proposals for international regulatory impact
• Maintain effective communication within the RA/QA group, as well as, cross-functional business partners, i.e. Product Development, Marketing, Legal, etc.
• Support Regulatory and Quality Departments efforts in maintaining ISO 13485 and MDSAP Certifications (internal audit, NB audits, SOP compliance, etc)
• May provide direct supervision of individual(s)

Global Regulatory Manager – Contract