Senior Regulatory Affairs Specialist

Regulatory Affairs and Quality Assurance Lead

Our client, a successful company in the medical devices distribution industry is currently searching for a Regulatory Affairs and Quality Assurance Lead to join their team at their new facility in Mississauga.

Responsibilities:

Act as single point of contact for regulatory issues and drive items to resolution within the organization;

Overseeing product complaint handling and assessment of device related incidents/complaints for medical device reporting requirements and applicable Health Canada reporting timelines

Submission of MDPR (Medical Device Problem Reporting) to Health Canada if applicable

Coordination of recalls with customers, suppliers and Health Canada

Ensure compliance of products and processes with Health Canada regulations including but not limited to thorough reviews of product labeling, advertising materials and promotional activities.

Prepare and compile regulatory submissions, responses to regulatory agency questions and other correspondence. Responsible for the preparation and assigning of product attributes of electronic documents for publishing to support regulatory submissions.

Maintain regulatory files/database and chronologies in good order. Establish and maintain the system for tracking changes in documents submitted to agencies or partners;

Research/Identify product licensing requirements and regulatory classification

Assists select suppliers with Health Canada Medical Device License Applications

Renewal and/or amendment of Health Canada Medical Device Establishment License (MDEL) and collaborate with internal stakeholders to develop and update standard operating procedures (SOPs) to ensure compliance with regulatory standards.

In the future, support the implementation of a quality management certification (including ISO program).

Skills and Qualifications:

Excellent verbal and written business level communication skills in English are a must

Bachelor’s degree in life science or relevant scientific field, additional Master of Science in Regulatory Affairs or Regulatory Affairs Certification preferred

Preferably, have a minimum of 3-5 years of experience with Health Canada, Medical Devices Regulations. Regulatory Administration, Product Complaint Handling, and/or SOP implementation in a Distribution environment are a definite asset

Experience reading, understanding and interpreting codes, standards, regulations and acts;

Ability to gather relevant information about internal processes, procedures and practices through research and discussions, analyze such data and prepare accurate and detailed documentation

Strong in understanding, executing and following governance and procedures with a questioning and analytical attitude/approach under minimum required supervision.

A passion for the industry with a desire to share with your peers

ISO /Certification Audit experience, and/or quality assurance background is an asset

Highly professional individual with a positive attitude

Strong work ethic, reliable and self-motivated, yet enjoy collaborating with team members

Must be able to multi-task and manage and meet timelines

Exceptional attention to details, meticulous by nature