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Initiate global regulatory strategies for new products and post-market changes.
Review post-market changes for devices currently marketed to determine regulatory impact.
Prepare and/or review US FDA 510(k) regulatory submissions and 510(k) letters to file to obtain/maintain U.S. market clearance.
Prepare and/or review technical documentation for Health Canada and submit regulatory recertifications and change notifications as appropriate.
Prepare and/or review appropriate documentation for initial submissions, change notifications, or renewals for EU MDR CE marked devices.
Keep up to date with changing regulations and educate cross functional peers on new medical device regulations, such as EU MDR or relevant guidance published by the FDA, etc.
Review international submissions to be submitted by our medical device company customers/partners.
Review and approve changes to currently marketed devices to determine impact to regulatory clearances / approvals.
Answer customer questions and provide letters/other documentation as is appropriate.
Support Notified Body and other regulatory agency audits.
Review and approve the rationale for reporting complaints to regulatory agencies and/or customers.
Ensure understanding of all quality policy/system items that are applicable.
Review and/or approve customer agreements for regulatory language that is relevant to the services provided.
Ensure that the information provided through the FURLS registration system with the FDA and the MDALL database in Health Canada is up-to-date and accurate regarding establishments licensing, owner/operator and medical device listings.
Update GUDID and/or EUDAMED database as needed for new and existing products.
Regulatory Affairs Specialist
Fridley, Minnesota$110K - $120K / yearPosted 1 weeks ago
Full-timehybridsenior