Job Description
Elevate your career as the Regulatory Affairs Lead at Norgen Biotek in Thorold, ON. This full-time position focuses on regulatory submissions, approvals, and ensuring product compliance.
In this on-site role, you will lead the preparation and coordination of documents for regulatory submissions to Health Canada, the FDA, and various ISO certifications. With 3+ years of experience in regulatory affairs and a related university degree, you will maintain critical knowledge on medical device regulations and liaise with authorities to navigate the compliance landscape.
Key Responsibilities:
• Compile documents for regulatory submissions to Health Canada and FDA
• Maintain certifications and approvals from various regulatory bodies
• Monitor regulatory changes and compliance for medical devices
• Support quality assurance on Good Manufacturing Practices
• Conduct post-marketing surveillance on medical devices
Requirements:<...
In this on-site role, you will lead the preparation and coordination of documents for regulatory submissions to Health Canada, the FDA, and various ISO certifications. With 3+ years of experience in regulatory affairs and a related university degree, you will maintain critical knowledge on medical device regulations and liaise with authorities to navigate the compliance landscape.
Key Responsibilities:
• Compile documents for regulatory submissions to Health Canada and FDA
• Maintain certifications and approvals from various regulatory bodies
• Monitor regulatory changes and compliance for medical devices
• Support quality assurance on Good Manufacturing Practices
• Conduct post-marketing surveillance on medical devices
Requirements:<...
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