Regulatory Affairs Specialist at DePuy Synthes

Join DePuy Synthes as a Senior Regulatory Affairs Specialist in Markham, Ontario, where your expertise in Medical Device regulation is crucial for innovative healthcare solutions.

In this senior role, you will develop and implement regulatory strategies for Class III and IV devices, ensuring compliance across the product lifecycle. You will collaborate with stakeholders, mentor junior staff, and improve the Quality Management System as you drive regulatory success.

Key Responsibilities:

• Develop Canadian Regulatory strategies for Class III and IV devices

• Manage lifecycle from pre-market to post-marketing phases

• Support internal and external compliance audits

• Mentor junior regulatory team members effectively

• Enhance Quality Management System compliance and efficiency

Requirements:

• Bachelor’s degree in Life Science, Engineering, or equivalent

• 3-5 years of experience in Medical Device Regulatory Affairs

• Proven ability to lead regulatory submissions

• Strong documentation and technical writing skills

• Experience with ISO 13485 and regulatory compliance

Utilize your regulatory expertise to drive healthcare innovations at DePuy Synthes in Markham.
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