29 Sep
|
Socket.dev
|
Brampton
29 Sep
Socket.dev
Brampton
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 complianceCollaborate with teams on regulatory strategy and changesReview submissions with management to resolve issuesInteract with agencies for approval processesSupport ongoing compliance efforts, including auditsRequirements:Bachelor's degree and minimum 2 years in regulatory affairsExperience in medical device regulations preferredAbility to analyze design and labeling for complianceEffective communication skills for team interactionProven project management skills in a fast-paced settingDrive impactful regulatory practices in healthcare with a key role at Medtronic.
📌 Medtronic Regulatory Affairs Specialist Role (Brampton)
🏢 Socket.dev
📍 Brampton