22 Sep
|
Socket.dev
|
Brampton
22 Sep
Socket.dev
Brampton
Enhance healthcare innovation as a Regulatory Affairs Specialist at Medtronic. Lead regulatory submissions and compliance efforts in a energetic healthcare setting that prioritizes patient welfare. As a Regulatory Affairs Specialist, you will be crucial in defining regulatory strategies and managing submissions for product maintenance. Engage with internal teams to ensure all document packages meet compliance standards while fostering relationships with regulatory agencies.
Your role will contribute significantly to the timely approval of medical devices, directly benefiting patient care. Key Responsibilities:
Manage submissions and document preparation for compliance
Collaborate with teams on regulatory strategy and changes
Review submissions with management to resolve issues
Interact with agencies for approval processes
Support ongoing compliance efforts, including audits Requirements:
Bachelor’s degree and minimum 2 years in regulatory affairs
Experience in medical device regulations preferred
Ability to analyze design and labeling for compliance
Effective communication skills for team interaction
Proven project management skills in a rapid-paced setting Drive impactful regulatory practices in healthcare with a key role at Medtronic.
📌 Medtronic Regulatory Affairs Specialist Role Brampton
🏢 Socket.dev
📍 Brampton