Enhance healthcare innovation as a Regulatory Affairs Specialist at Medtronic. Lead regulatory submissions and compliance efforts in a dynamic 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 fast-paced setting
Drive impactful regulatory practices in healthcare with a key role at Medtronic.
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