About This Opportunity: Regulatory Affairs Lead (Newfoundland and Labrador)
VB Spine is currently seeking a Regulatory Affairs Lead (Newfoundland and Labrador) to join their team in Newfoundland and Labrador.
This position offers an excellent opportunity for motivated individuals looking to advance their career.
Education Requirements
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No specific education requirements
Required Experience
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changing spinal procedures. We’re the largest privately held spine company and among the largest family‑owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Senior Specialist, Regulatory Affairs in our Regulatory Affairs function supporting the Spine division in Canada, you’ll play a key individual contributor role in preparing and coordinating regulatory submissions, ensuring compliance with local and regional requirements, and supporting the successful registration and maintenance of medical devices across the Canadian market.
What You’ll Do:
Coordinate and prepare document packages for regulatory submissions for new and mature products to ensure alignment with Canadian and regional registration requirements
Compile all materials required for submissions, license renewals, and annual registrations
Recommend changes to labeling, manufacturing, marketing materials, and clinical protocols to achieve and maintain regulatory compliance
Support internal audits and inspections by preparing documentation and responding to regulatory inquiries
Monitor and improve tracking and control systems for regulatory submissions and compliance activities
Stay current with evolving regulatory procedures, guidelines, and changes in Canadian medical device regulations
Work cross‑functionally with R&D;, Quality, Clinical, and Marketing teams to gather necessary documentation and ensure timely submissions
Perform detailed reviews and evaluative judgements on regulatory documentation to maintain high standards of accuracy and compliance
What You Bring:
Bachelor’s degree in a scientific, engineering, or related discipline (or equivalent combination of education and experience)
2+ years of experience in regulatory affairs, preferably in the medical device industry
Solid understanding of Canadian medical device regulations (Health Canada) and familiarity with international standards (e.g., ISO 13485, MDR)
Strong attention to detail with excellent organizational and document management skills
Ability to work independently with minimal supervision and apply professional judgement
Effective communication and collaboration skills to work with cross‑functional teams
Proficiency in compiling technical documentation and preparing submission packages
Proactive approach to staying updated on regulatory changes and improving processes
Why VB Spine?
We believe in growing talent from within. At VB Spine, join a high‑performing team, benefit from peer and executive mentorship, and contribute directly to bringing innovative spinal technologies to the Canadian market through robust regulatory compliance and submissions excellence.
Compensation:
Pay for this role is $85,000.00
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$110,000 USD based on experience, qualifications, and performance with potential for bonuses and incentives plus benefits. Final compensation is determined on a case‑by‑case basis and considers a variety of factors including experience level, regulatory expertise, and local market conditions in Burlington, Ontario.
Benefits include:
Comprehensive health, dental, and vision insurance
Retirement savings plan with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunity to grow within a fast‑paced, dynamic company
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Position Details
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Location: Newfoundland and Labrador
Key Responsibilities
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Effectively perform assigned job duties
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Maintain safety and cleanliness in the workplace
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Work effectively with team members
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Follow company policies and procedures
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Perform tasks according to quality standards
Qualifications
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Reliability and punctuality
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Ability to work independently and in a team
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Strong work ethic and positive attitude
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Ability to follow instructions
Why Join VB Spine?VB Spine offers a supportive work environment in Newfoundland and Labrador, where employees can grow and develop their skills. This Regulatory Affairs Lead (Newfoundland and Labrador) position provides the opportunity to work with a dedicated team and contribute to meaningful work.
Ready to Apply?
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