Regulatory Affairs Specialists
Medtronic - Santa Rosa, CA

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Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description

Provide worldwide premarket and postmarket regulatory affairs support; develop worldwide regulatory strategic level plans and complete premarket and postmarket regulatory deliverables for Class II and III medical devices, including project planning and coordination; assess device changes for worldwide regulatory implications; coordinate submission activities for regulatory approvals including pre-market approvals, post-market reporting and changes, international design dossiers, Shonins, Device License Applications, post-approval reports, export certificates, clinical trial exemptions and establishment registration and listings; develop strategies for regulatory approval; write and coordinate domestic regulatory submissions including original IDE, PMA, and 510(k) submissions and supplements and similar clinical and market approval submissions worldwide; write and coordinate international regulatory documents including but not limited to EU Design Dossiers, Canadian Device License Applications, and Japanese Shonins based on current global regulatory requirements; review product labeling to assure compliance with worldwide regulatory requirements; handle field actions or review of proposed device changes; review device labeling, advertising, sales support and training materials for compliance; assess product and manufacturing changes for compliance; manage product dossiers, technical files, and other worldwide regulatory dossiers; monitor emerging worldwide regulatory trends and integrate new requirements; provide regulatory support and leadership to product manufacturing transfers and for product design, manufacturing, packaging, sterilization, and labeling changes; provide product regulatory affairs leadership for product development and manufacturing; provide regulatory input for compliance with ISO, Japan, and FDA and other global Quality System Regulation (QSR) requirements; serve as internal consultant on regulatory issues; review and analyze technical data generated by R&D, Marketing/Sales, Clinical Research, Quality Assurance and other related departments; and, develop and deliver presentations to global regulatory agencies. Required to travel 10% to 20%.
Position Responsibilities

Same as above
Basic Qualifications

Master’s degree in Engineering, Regulatory Science, Life Sciences or related medical/scientific field and six months of experience in regulatory affairs, engineering or related field; or a Bachelor’s degree in Engineering, Regulatory Science, Life Sciences or related medical/scientific field and five years of progressive experience in regulatory affairs, engineering or related field. Must possess experience or coursework in the regulation of medical devices or experience working with medical devices; experience with medical device submissions and clearances; knowledge of worldwide medical device regulations; knowledge of current worldwide regulatory requirements, such as FDA medical device regulations, EU Medical Device Directive, Canadian or Japanese medical device regulations; and, experience with technical writing. Travel required 10% to 20%.
Desired/Preferred Qualifications

Physical Job Requirements

Medtronic - 16 months ago - save job - block
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About this company
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Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...