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17 Jul 2026
Regulatory Affairs Project Manager
Ottawa, ON
Lead Global Regulatory Projects in IVD Diagnostics and Help Bring Innovative Medical Devices to MarketAgilus by Synergie is recruiting for a Regulatory Affairs Project Manager in the Life Sciences Industry in Ottawa, Ontario. Are you an experienced Regulatory Affairs professional with a passion for project leadership and global medical device compliance?
We are seeking a Regulatory Affairs Project Manager to lead regulatory initiatives supporting the development, registration, and lifecycle management of innovative In Vitro Diagnostic (IVD) medical devices. In this contract role, you'll collaborate with international stakeholders, drive regulatory project execution, and help ensure successful market access across key global regions. Responsibilities:- Develop and execute regulatory strategies supporting IVD medical devices throughout the product lifecycle
- Lead regulatory workstreams and align deliverables with project objectives and timelines
- Create and maintain project plans, schedules, and regulatory milestones
- Monitor project risks, issues, and dependencies while implementing mitigation plans
- Facilitate project meetings, stakeholder communications, and status reporting
- Coordinate regulatory activities with international teams and business partners
- Support regulatory submissions, registrations, and market authorization activities
- Assist with post-market and ongoing regulatory compliance activities as required
Requirements:- Hold a Bachelor's degree in Life Sciences, Biomedical Engineering, Biotechnology, Regulatory Affairs, Medical Technology, or a related discipline
- 5-8 years of Regulatory Affairs experience within the medical device or IVD industry
- Demonstrate 2-3 years of project management experience leading regulatory initiatives
- Possess experience preparing and managing IVD regulatory submissions in major global markets
- Apply knowledge of EU IVDR and Health Canada Medical Device Regulations
- Demonstrate experience working within ISO 13485-compliant quality systems
- Showcase strong written, verbal, and stakeholder communication skills
- Utilize advanced computer skills including SharePoint, Excel, and related business applications
Total compensation:- $85000.00 - $103000.00 annually
- Weekly pay including 4% vacation pay
- Work on a long-term contract running from August 2026 through December 2027
- Option to opt-in to Health and Dental Benefits with Agilus
- Transit accessible and free parking
Soft skills:- Strong communication skills and ability to collaborate with others
This posting is for an active opening. Let's connect! Please apply directly online Agilus by Synergie would like to thank all candidates for their interest in this opportunity. Due to the volume of resumes we receive; we may only be able to respond directly to those candidates being selected for an interview.We encourage you to visit agilus.ca regularly or subscribe to our email alerts at agilus.ca/Account/Register as new exciting employment opportunities become available daily.
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