Regulatory Affairs Analyst

Smith+Nephew•Field, ON

3d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about regulatory affairs and making a meaningful impact on patient outcomes? Join us as a Regulatory Affairs Analyst, where your expertise will help bring innovative medical technologies to market while ensuring compliance and quality across the product lifecycle. This position offers the chance to collaborate with global teams and influence regulatory strategy in a dynamic and purpose driven environment.

Requirements

Bachelor’s degree in science, business, or a related discipline
Approximately 3 to 5 years of experience in regulatory affairs within the medical device or regulated healthcare industry
Strong knowledge of the Canadian Food and Drugs Act and related regulations
Experience with Quality Management Systems and ISO 13485
Excellent communication, organization, and project management skills
Ability to work autonomously while collaborating effectively in cross functional and global teams
Fluency in written and spoken English, with French considered an asset

Responsibilities

Supporting the development and execution of Canadian regulatory strategies to achieve and maintain market authorization for medical devices
Preparing and maintaining regulatory submissions and licenses including MDEL and related Health Canada requirements
Providing regulatory guidance to quality, operations, and cross functional teams to ensure ongoing compliance
Reviewing and approving device labeling and promotional materials in line with Canadian regulations
Assessing product and process changes for regulatory impact across the product lifecycle
Supporting Quality Management System activities and maintaining GMP related records
Acting as a signing authority with Health Canada for GMP activities and regulatory communications
Contributing to the development and maintenance of SOPs and supporting continuous improvement initiatives
Collaborating with internal and external partners, including global regulatory and quality teams