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For your reference, we have included the original job posting below.
Prin Regulatory Affairs Spec Job
Job Number:
25337483
Company Name:
Medtronic
Job Location:
Fridley, MN US
Job Category:
Healthcare & Medical
Prin Regulatory Affairs Spec Job
Prin Regulatory Affairs Spec
Requisition 72371 Category Regulatory Affairs and QA Business Neuromodulation Division Neurological Regulatory Location USA-MN-Mpls-Fridley Relocation Relocation eligibility to be determined Job Type Full Time - Regular Exempt/Non-Exempt Exempt Shift First Travel Percentage less than 10% Experience Required 7 years Education Required Bachelor of Science
Medtronic is an Equal Opportunity/Affirmative Action Employer
Position Description
The Principal Regulatory affairs Specialist is responsible for developing regulatory strategy, preparing U.S. and international submissions and obtaining approval to introduce new products and therapies to markets worldwide.
Position Responsibilities
Team with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Review only significant submission decisions/content issues with manager. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as needed. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Provide business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to business teams. Provide feedbacks and on-going support to product development teams for regulatory issues and questions. Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high quality work. May mentor or supervise other RAS, as directed by manager.
Basic Qualifications
7+years industry experience and a minimum of 3 years in Regulatory Affairs with Bachelor's Degree Direct work experience in 510Ks IDEs, PMA, PMA supplements . Bachelor's degree in a scientific discipline.
Desired/Preferred Qualifications
Strong organizational, communications and leadership skills Strong writing skills required with ability to analyze and present data Familiar with QSR, GMP, and ISO requirements Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills. Ability to effectively manage multiple projects and priorities. Computer literate in MS Office and Word Experience with Class III/IV medical devices or pharmaceuticals Medtronic product development experience Experience with FDA and international regulatory agency requirements, ISOIGHTF standards Project management skills Advanced degree in a scientific discipline Clinical study involvement Compliance/Vigilance experience desired (e.g. PCRs, MDRs, vigilance reporting
