Quality & Regulatory Compliance Specialist

bioMérieux SA; Saint-Laurent; On-site; CAD 60,000 - 80,000; Full time

Job summary

A healthcare solutions company in Canada seeks a skilled regulatory compliance officer to ensure adherence to Medical Devices Regulations and Quality Management System requirements. This role involves monitoring compliance, participating in audits, and supporting commercial operations with quality-related requests. Candidates should possess a bachelor's degree in a relevant field, with at least 2 years of experience in the Medical Devices sector. Strong communication and computer skills are crucial for success.

Qualifications

• Requires 2+ years related experience in the Medical Devices Industry.
• Knowledge of Canadian Medical Devices Regulations is necessary.
• Knowledge of ISO 9001 standard and Quality Management System is essential.

Responsibilities

• Ensure compliance with recall requirements of the Canadian Medical Devices Regulations.
• Assist in the execution and improvement of regulatory processes.
• Participate in audits and manage the Quality Management System.

Skills

Strong computer skills

Good verbal communication

Proven collaboration skills

Time management skills

Adaptability

Autonomy

Education

Bachelor's degree in Science, Biology or Quality

Master's Degree

Tools

Microsoft Office Package

Trackwise

SAP

Job description

A healthcare solutions company in Canada seeks a skilled regulatory compliance officer to ensure adherence to Medical Devices Regulations and Quality Management System requirements. This role involves monitoring compliance, participating in audits, and supporting commercial operations with quality-related requests. Candidates should possess a bachelor's degree in a relevant field, with at least 2 years of experience in the Medical Devices sector. Strong communication and computer skills are crucial for success.