Regulatory Manager
1 week ago
Posted On 2025-03-06
Job Information
Autres/others
City Pointe-Claire
State/Province Quebec
H9R
Job Description
At Caméléon RH, we believe that happiness at work comes from the perfect match between the right role, the right company, the right leader, and an environment that truly stimulates you
We are here to listen, understand, and get to know the person behind the resume. Our commitment is to present opportunities that will allow you to thrive both professionally and personally.
As a Regulatory Manager, you will lead the regulatory team, ensuring compliance with Canadian and US health authorities while supporting product commercialization and business growth. You will develop regulatory strategies, oversee regulatory submissions, and maintain compliance for medical devices, natural health products, and pharmaceuticals. Your leadership will foster a proactive, risk-based approach to regulatory affairs, ensuring business objectives are met while maintaining regulatory excellence.
Your Daily Responsibilities:
- Develop and implement regulatory strategies to support product commercialization.
- Ensure compliance with US and Canadian regulations for medical devices, health products, and drug products.
- Serve as the company's regulatory representative with health authorities (US and Canada).
- Lead regulatory submissions for new products, line extensions, and label updates.
- Assess regulatory risks and provide strategic guidance to internal teams.
- Monitor and analyze regulatory trends, ensuring proactive adjustments to compliance strategies.
- Oversee post-marketing regulatory compliance, including safety reporting and product maintenance.
- Support M&A activities, ensuring regulatory due diligence and compliance in acquisitions.
- Coach, mentor, and lead the regulatory team, driving performance and professional growth.
Your Must-Haves:
- Bachelor's degree in Engineering, Life Sciences, or Regulatory Affairs.
- Minimum 8 years of experience in regulatory affairs, preferably in medical devices.
- 5+ years of leadership experience, managing regulatory teams.
- Strong knowledge of US and Canadian regulations for medical devices, health products, and pharmaceuticals.
- Experience in regulatory submissions and approvals for new and innovative products.
- Ability to navigate complex regulatory frameworks with a risk-based approach.
- Excellent communication and negotiation skills to interact with regulatory agencies.
- Experience in project management and cross-functional collaboration.
An Asset to Have:
- Master's degree and/or professional certification in a scientific, engineering, or regulatory discipline.
- Experience in M&A regulatory assessments and global regulatory frameworks.
6 Great Reasons to Apply:
- Comprehensive insurance program, including EAP and telemedicine for you and your family.
- Numerous training, coaching, and professional development opportunities.
- A friendly and dynamic work atmosphere, with social events, sports, BBQs, and more
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