Regulatory Affairs Specialist
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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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
Must Have: Minimum Requirements
Education
- University Degree in Life Sciences
- Post graduate certificate in Regulatory Affairs
Knowledge
- Excellent knowledge of the Food and Drugs Act and Regulations
- Knowledge of the Canadian Medical Devices Regulations
- Knowledge of Quality System Requirements
Job Experience
- Minimum of 5 years of relevant experience, or advanced degree with 2 years of experience
- Experience in the preparation and filing of medical devices submissions
- 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.).
Knowledge of SAP an asset
Knowledge of Software, Cybersecurity and/or Artificial Intelligence an asset.
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
