· Set up and manage processes for handling product recalls, medical device reporting (MDR/MPR), and critical customer complaints.
· Take the lead on preparing and submitting reports for MDRs, MPRs, recalls, and Field Safety Correction Actions (FSCAs).
· Act as the go-to expert during regulatory inspections and audits.
· Build and maintain strong working relationships with internal teams, external partners, and industry experts
· Make sure all regulatory submissions are accurate and sent on time.
· Write and manage customer notifications and documentation for field corrections, keeping everything well-documented for compliance.
· Organize and send out customer communications using both internal resources and external vendors.
· Work closely with global sites and regulatory teams to ensure procedures are followed properly.
· Communicate directly with regulators like the FDA and Health Canada on things like recalls and vigilance reports.
· Handle required product removals or recalls quickly and effectively.
· Lead investigations into critical complaints and work with cross-functional teams to find solutions.
· Use data analysis and reporting to spot trends and catch potential systemic problems early.
· Jump in to help with other tasks as needed.