Regulatory Affairs Associate

Value Proposition

As a leading partner in healthcare, Medline Canada's sole purpose is Together Improving Care – this means being deeply committed to the health and well-being of our customers, employees, partners and our communities. We employ a diverse group of top talent focused on growing and making a difference in the lives of Canadians, coast-to-coast.

Compensation is only one part of the Employee Value Proposition that Medline Canada offers our employees. As part of our mission, we offer one of the most competitive and engaging employee experience programs in Canada, which includes:

• Collaborative work environment with highly engaged employees
• Market competitive compensation and benefits plan, including LTD & Insurance
• DPSP match program
• Annual Employee Appreciation Week
• Paid vacation and personal days
• Lifeworks Employee Assistance Program (EAP) Resources supporting mental, physical, family and financial well-being
• Career growth and training programs
• Open communication with Senior Leaders
• Tailored incentives for eligible employee groups, such as home office reimbursement and Sylvan Learning Centre credit
• Employee referral program
• Education support programs
• Fitness subsidy
• Recognition programs
• Social activities
• And much more…

JOB SUMMARY

The Regulatory Affairs Associate assists with the preparation of regulatory applications and helps overall in obtaining regulatory clearance for selling products on the Canadian market. This is an entry-level role, supporting the RA department

CORE JOB RESPONSIBILITIES

• Perform regulatory screening of new products to ensure compliance with Health Canada requirements.
• Prepare summary reports for devices, drugs and NHPs, but collecting and compiling data, as well as providing an analysis.
• Assist in the preparation and submission of medical device licence applications, and support amendments and renewals of MDELS and DELs.
• Manage and requisition regulatory and quality documents, maintaining accuracy and timely access for stakeholders.
• Respond to customer requests for regulatory information.
• Respond to miscellaneous requests from Medline personnel on regulatory matters and other miscellaneous duties as required from time to time.
• Work directly with Medline Corporate Divisions to obtain required information for product applications.

QUALIFICATIONS

• BSc or equivalent.
• Post Graduate Diploma in Regulatory/Quality Program preferred.
• Basic regulatory knowledge. Further knowledge to be gained on the job over a period of 6 months to 1 year.
• Basic knowledge of product classification under Health Canada, particularly for medical devices.
• Familiarity with the medical device licence application process.
• Experience or exposure to drug and Natural Health Product (NHP) submissions is an asset.
• Understanding of Medical Device Establishment Licences (MDEL), Drug Establishment Licences (DEL), and site licences is an asset.
• Proficiency in Microsoft Excel, with intermediate-level skills.
• Strong oral and written communication skills, with the ability to present technical information effectively.
• Detail-oriented mindset with strong organizational skills to manage multiple projects and deadlines.
• Analytical skills to interpret and apply regulatory requirements effectively.

About Medline Canada

Medline Canada stands at the forefront of healthcare, providing expertise and a breadth of solutions for every care setting. With 550+ employees, including 100 dedicated sales and clinical professionals and eight distribution centres located coast-to-coast, Medline Canada is proud to serve the entire continuum of care.

Our Commitment to Diversity and Inclusivity

Medline Canada is committed to diversity and inclusivity and we encourage applications from members of groups that have been historically disadvantaged and marginalized, including First Nations, Metis and Inuit peoples, Indigenous peoples of North America, racialized persons/persons of colour and those who identify as women, persons with disabilities and LGBTQ+ persons.

Our commitment to Accessibility

Medline Canada is committed to the principles of the Accessibility for Ontarians with Disabilities Act (AODA). We endeavor to make our recruitment, assessment and selection processes as accessible as possible and provide accommodations as required for applicants with disabilities. If you require any accommodations at any point during the application and hiring process, please contact [email protected].

All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.