Regulatory Affairs Specialist
📋 Role Overview & Responsibilities
Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2
Job Summary We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manufacturing operations, and providing regulatory guidance. Experience with international product registrations and electronic document control systems is a plus.
Responsibilities:Implement and maintain the effectiveness of the quality systemSupport manufacturing/operations day-to-day activities for change controlProvide consultation/advice to regulatory specialist for change control and product developmentProvide regulatory direction/interpretation on team activitiesInterpret and apply regulatory understanding to support products and teamsPrepare U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwideHandle regulatory activities involved in documentation, labeling, field supportApply regulatory and technical knowledge to a wide variety of complex work assignmentsMaintain and ensure compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supportsEnsure compliance to and demonstrate knowledge of site and division level policies and procedures
Qualifications:2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs functionKnowledge of regulations and standards affecting IVDs and/or biologicsBS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.Experience with international (outside of EU and US) product registrations preferredExperience working with medical device operations on control of product release preferredExperience working with electronic change management/document control systems preferred
Term & Start6- month contract FT, M-F 40hr/weekPay Rate: $50-55/HR (100-110K Annually) Onsite in Santa Clara, CA
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This position is located in Santa Clara, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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