Research Officer
About The Position
The Research Officer is responsible for providing regulatory affairs support for medical device clinical investigations. This includes preparing and submitting Investigational Testing Authorization (ITA) applications to Health Canada, and providing support throughout the authorization process. The incumbent will prepare and review regulatory documentation and other supporting technical documentation required for clinical investigations. The incumbent of the position act as the primary regulatory contact with Health Canada, responding to requests for additional information and organize submission activities. The role also includes assessing regulatory requirements, advising on applicable Canadian medical device regulations and guidance, evaluating the regulatory impact of proposed device changes, and providing regulatory input on clinical study design and execution.
Requirements
- Bachelor's Degree
- 3 Years Related Experience
- Authorized to work in Canada
- Willing to work in the province of Quebec
- English communication skills (verbal and written) at level #4 (qualifier) on a scale of 0-4.
Responsibilities
- Providing regulatory affairs support for medical device clinical investigations.
- Preparing and submitting Investigational Testing Authorization (ITA) applications to Health Canada.
- Providing support throughout the authorization process.
- Preparing and reviewing regulatory documentation and other supporting technical documentation required for clinical investigations.
- Acting as the primary regulatory contact with Health Canada, responding to requests for additional information and organizing submission activities.
- Assessing regulatory requirements.
- Advising on applicable Canadian medical device regulations and guidance.
- Evaluating the regulatory impact of proposed device changes.
- Providing regulatory input on clinical study design and execution.
Benefits
- Competitive benefits package (Health, Dental, Life Insurance) (if eligible)
- Defined contribution pension plan (with employer contribution up to 10%) (if eligible)
- Group Registered Retirement Savings Plan (RRSP) and Tax Free Savings Account (TFSA)
- Competitive vacation policy
- Two (2) personal days
- Two (2) floating holidays
- Nine (9) "Summer Fridays" - paid days off between the St-Jean Baptiste holiday and Labour Day
- Paid time off over the December holiday period
- Tuition waiver for regular employees and their dependents
- Up to two (2) days of remote work per week where the position permits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
