Regulatory Specialist

Your challenge

• Establish and maintain procedures for recalls, medical device reporting (MDR/MPR), and critical complaint handling.

• Lead, manage, and prepare submissions for MDRs, MPRs, recalls, and Field Safety Correction Reports (FSCA).

• Serve as the subject matter expert (SME) during regulatory inspections and audits. 

• Develop and maintain strong relationships with internal teams, external stakeholders, and key opinion leaders (KOLs).

• Ensure timely and accurate submissions to regulatory authorities.

• Prepare customer notifications, communications, and documentation related to field corrections. Maintain essential records for regulatory complaince. 

• Coordinate customer communication mailings using internal and third-party resources.

• Collaborate with GBO sites and regulatory professionals per company procedures.

• Interface directly with the FDA, Health Canada and other regulator...