Associate Regulatory Affairs Specialist

**Careers that Change Lives**
Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it’s like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.
- Bring your talents to an innovative medical technology and healthcare solutions leader. We deliver with the training, mentorship, and guidance to build your future success.

**A Day in the Life**
- Performs coordination, preparation, compilation and review of technical documents required for regulatory submissions to Health Canada for approval/licensing of Medtronic products in Canada.
- Maintain ongoing dialogue with business partner(s) to align with the business plan.
- Liaise with Senior Regulatory Affairs Specialists to align on strategy and submission planning
- Maintain professional relationship with Health Canada.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- Ensure all regulatory records are properly and adequately maintained in accordance with regulatory requirements and internal processes.
- Support special Regulatory business projects and assignments as required.

**Must Have: Minimum Requirements**
- Minimum of 2 years of relevant experience, with a bachelor’s degree, or;
- Bachelor’s degree in Engineering or Life Sciences,

**Nice to Have**
- Strong problem solving and organizational skills and able to work with minimum supervision.
- Detail oriented, accurate and results driver.
- Ability to think strategically and work in cross-functional teams.
- Ability to manage multiple priorities in a fast-paced environment.
- Team player with very strong interpersonal skills.
- Excellent verbal and written communication skills.
- Must be computer literate using Microsoft software (i.e. Word, Excel, PDF, etc.).
- Postgraduate Certificate in Regulatory Affairs.
- Working knowledge of the Food and Drugs Act and associated Regulations.
- Knowledge of Quality System Requirements
- Must be computer literate using Microsoft software (i.e. Word, Excel, PDF, etc.).

**About Medtronic**

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

**Physical Job Requirements**

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)