Regulatory Affairs Manager
1 week ago
**Position**: Regulatory Affairs Manager
**Location**: Based out of Burlington, Ontario or Vaudreuil-Dorion, Quebec (Hybrid / Flexibility Policy)
**Status**: Permanent, full-time
As a strong regulatory manager, you will bring your comprehensive knowledge of regulatory compliance, meticulous attention to detail, and strong analytical skills to ensure our organization's adherence to regulatory requirements. In this role, you will have the opportunity to lead and inspire a talented team, fostering a culture of excellence and driving successful outcomes. By joining our team as a Regulatory Affairs Manager, you will be instrumental in shaping the future of our organization and making a positive difference for our valued clients.
About your future team
At Quadra, we put people first so that together, we can reimagine the possibilities.
Based in Burlington, Ontario or Vaudreuil-Dorion, Quebec, our modern head office is home to over a hundred fun-loving professionals. Of course, you can always take advantage of our hybrid telecommuting policy. Founded over 45 years ago, Quadra is dedicated to its 550+ employees located in Canada and the United States. Quadra Chemicals is one of the largest distributors of chemicals and ingredients in the Canadian marketplace. With multiple facilities across Canada, we are committed to delivering excellence in everything we do. We are a rapidly growing company with a long-term commitment to our employees. If you are committed to excellence, you belong at Quadra. At Quadra, we have created an environment where people are a priority and opportunities are growing. Our culture based on our core values of entrepreneurship, innovation and caring make us an employer of choice.
We believe in fostering a work environment that challenges and empowers individuals, providing ample opportunities for personal growth and development. We recognize and celebrate outstanding performance, ensuring that your dedication and achievements are duly acknowledged.
What will you bring to the team?
- A strong technical knowledge of pertinent government regulations and associated compliance requirements as well as insight in determining compliance pathways for new business areas developed by the company
- Being an active member with industry associations, including, but not limited to, participation on the Responsible Distribution Canada’s and NACD
- Excels in managing priorities, is resourceful and a relationship-builder
- Being known as a positive leader that works well with cross-functional teams (QA, Sales, Operations, etc.)
- Being acknowledged by peers as an expert in order to respond to external requests related to regulatory affairs
- Excellent communicator, focused on customer service, curious and eager to achieve excellence for his/her team
- Strong attention to detail, accuracy and precision
- A passion for the industry with a desire to share with your peers
**You would be responsible for**:
**Team Management**:
- Leading department workflow to ensure a structured approach to compliance activity
- Ensuring that regulatory compliance activity meets all government requirements, and that department output is meeting Quadra’s commercial needs for efficient integration of compliance oversight in business operations
- Supervision of team members; establish departmental goals, action plans and strategies as well as mentoring/coaching, managing performance, hiring, onboarding, etc.
- Work in collaboration with the Director, Compliance Assurance to establish department goals and objectives
New Product Regulatory Evaluation and Set-Up, Ongoing Regulation Compliance:
- Development and implementation of efficient Regulatory Affairs procedures to determine the CEPA/TSCA status of all new products and the identity of product ingredients
- Mentoring the Regulatory Affairs team regarding CEPA new substance screening activities
- Managing new product screening procedures that encompass compliance with many other product use regulations which reflect the wide diversity of industry sectors served: Food & Drugs Act and associated regulations, Transportation of Dangerous Goods Regulations, Drug Precursor Regulations, Explosive Regulations, WHMIS/GHS and additional Quadra internal requirements such as product High Risk classification
- Management of new product set-up workflow to facilitate a robust and efficient compliance program
- Product Registration Activity: Preparation and submission of pertinent product use approval submissions (i.e. NSN, fertilizers, animal feeds, pesticides, biocides, Food & Drug related use approvals, etc.)
- Management of regulation compliance (for existing regulations) to include procedure revisions when regulations are updated
CEPA and TSCA Substances Management
- Monitoring of Canada Gazette and other industry association resources to identify government mandated reporting activities associated with chemical product importation and sales
- Supervising Quadra Significant New A
-
Director of Regulatory Affairs
3 weeks ago
Ottawa, Canada Mining Association of Canada Full timeOrganizational Profile The Mining Association of Canada (MAC) is the national organization for the Canadian mining industry. Its members account for the majority of Canada's production of base and precious metals, uranium, diamonds, metallurgical coal and mined oil sands, and are actively engaged in mineral exploration, mining, smelting, refining and...
-
Director of Regulatory Affairs
3 hours ago
Ottawa, Canada Mining Association of Canada Full timeOrganizational ProfileThe Mining Association of Canada (MAC) is the national organization for the Canadian mining industry. Its members account for the majority of Canada’s production of base and precious metals, uranium, diamonds, metallurgical coal and mined oil sands, and are actively engaged in mineral exploration, mining, smelting, refining and...
-
Director of Regulatory Affairs
1 day ago
Ottawa, Ontario, Canada Mining Association of Canada Full timeOrganizational ProfileThe Mining Association of Canada (MAC) is the national organization for the Canadian mining industry. Its members account for the majority of Canada's production of base and precious metals, uranium, diamonds, metallurgical coal and mined oil sands, and are actively engaged in mineral exploration, mining, smelting, refining and...
-
Ottawa, Canada Celestrahealth Full timeJob Application and Information for: Job - Quality System and Regulatory Affairs Specialist (Ottawa Based)Position OverviewWe are currently seeking a detail-oriented Quality System Associate/Specialist to join our team, who is also well-versed in EU MDR and FDA medical device regulations. This position includes the following responsibilities:Supporting the...
-
Ottawa, Canada Celestrahealth Full timeJob Application and Information for: Job - Quality System and Regulatory Affairs Specialist (Ottawa Based) Position Overview We are currently seeking a detail-oriented Quality System Associate/Specialist to join our team, who is also well-versed in EU MDR and FDA medical device regulations. This position includes the following responsibilities: Supporting...
-
Ottawa, Canada Boston Scientific Gruppe Full timeA leading medical technology company is seeking a Regulatory Affairs professional for a 20-month contract in Ottawa, Canada. The role focuses on supporting regulatory submissions and compliance for Class III medical devices used in liver cancer treatment. Candidates should have at least 5 years of experience in the medical device industry, knowledge of FDA...
-
Reg Affairs Specialist II
1 day ago
Ottawa, Ontario, Canada Boston Scientific Full timeBachelor's degree (minimum). At least 5 years of Regulatory Affairs experience within the medical device industry. Working knowledge of FDA, EU, and/or international medical device regulations. Hands-on submission experience, such as Design Dossier and Technical File reviews, PMA/510(k) submissions, and/or international submissions. Degree in a scientific,...
-
Reg Affairs Specialist II
2 days ago
Ottawa, Ontario, Canada Boston Scientific Full timeAdditional Locations: Canada-ON-OttawaDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
-
Reg Affairs Specialist II
4 weeks ago
Ottawa, Canada Boston Scientific Gruppe Full timeSelect how often (in days) to receive an alert: Create Alert Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry...
-
Regulatory Strategy Lead, Crop Protection
3 weeks ago
Ottawa, Canada Vive Crop Protection Inc Full timeA leading agricultural science company is seeking a Regulatory Affairs Specialist in Ottawa, Ontario. This role involves coordinating submissions to the PMRA and US-EPA, developing regulatory strategies, and preparing dossiers. Ideal candidates should have a degree in a scientific discipline, over 4 years of experience in regulatory affairs, and strong...