Regulatory Affairs Analyst

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.
 

What will you be doing?

• 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

What will you need to be successful?

• 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

The anticipated base compensation range for this position is $79,750 - $119,500 CAD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, RRSP, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as the Employee Assistance Program.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.  

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ 

• Investing In Your Future: RRSP Programs, Tuition Reimbursement

• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Floating Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Employee Assistance Program, Parental Leave

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more!

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