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Regulatory Affairs Associate

ProClinical - North Chicago, IL

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Job Description

Proclinical is seeking to hire a Regulatory Affairs Associate located in North Chicago, IL. As the Regulatory Affairs Associate, you will establish and maintain submission content planners and associated timelines, facilitate tactical submission team meetings, prepare content planners for publishing, interface with publishing vendor, and fulfill Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.Job Responsibilities:Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approvalAuthoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports)Review/approval of engineering study protocols/reports and validation study protocols/reportsReview and approval of manufacturing changes for Class III implantable medical devicesMay require an advanced degree and 8+ years of direct experience in the fieldRecent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulationsRelies on extensive experience and judgment to plan and accomplish goalsPerforms a variety of tasks. May lead and direct the work of othersA wide degree of creativity and latitude is expectedTypically reports to a manager or head of a unit/departmentSkills and Requirements:Minimum Bachelor''s degree4+ years of experience in PharmaIf you are having difficulty in applying or if you have any questions, please contact Kate Heffernan at (+1) 610-624-3327 or [Click Here to Email Your Resumé].Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.LI-KH1

Created: 2025-10-04

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