Join Olympus as a Regulatory Affairs Specialist, working in a hybrid setup across Ontario. Leverage your extensive regulatory knowledge to manage product registrations and ensure compliance with Canadian standards.
This position involves supporting Olympus Canada Inc. with regulatory activities related to medical devices. You will take charge of preparing submission documents, mentoring junior staff, and collaborating with various teams to integrate regulatory requirements into product design. Your role is crucial for overseeing compliance and enhancing product development initiatives.
Key Responsibilities:
• Oversee regulatory submission creation and guidance
• Collaborate with SMEs on product license applications
• Identify impacts from changes in Canadian regulations
• Review marketing materials for compliance
• Develop and maintain regulatory documentation
Requirements:
• BS/BA in engineering or life sciences
• At least 5 years' regulatory experience
• Excellent verbal and written communication skills
• Robust teamwork and organizational abilities
• Willingness to travel domestically and internationally
Your regulatory expertise can significantly impact Olympus's mission in healthcare innovation.
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