Regulatory Affairs Associate II

Now Hiring: Regulatory Affairs Specialist – Medical Devices Irvine, CA – Hybrid Onsite Tuesday, Wednesday & Thursday Pay: $43-$48/hr Required Qualifications 3–5 years of direct Regulatory Affairs experience , preferably within the medical device industry Recent experience supporting Class IIb medical devices in the EU Strong working knowledge of EU MDR 2017/745 Demonstrated experience authoring, submitting, and obtaining approval of Class IIb variations and/or renewals Experience supporting new medical device submissions, license renewals, and post-approval variations Experience assessing and supporting regulatory submissions associated with manufacturing site or manufacturing process changes International regulatory submission experience outside the U.S., including one or more of the following regions: JAPAC/APAC – Singapore, Malaysia, Hong Kong, Vietnam MEAR – South Africa, Botswana and other African markets LATAM – Brazil, Mexico Experience preparing and coordinating responses to Health Authority questions related to submissions, renewals, and variations Experience reviewing engineering study protocols/reports and validation protocols/reports Strong cross-functional communication skills with the ability to work effectively with R&D, Engineering, Manufacturing, Operations, and Regulatory teams We are seeking an experienced Regulatory Affairs professional to support global medical device regulatory activities, including new device submissions, renewals, variations, manufacturing changes, and lifecycle management. This role will partner closely with R&D, Operations, Engineering, Manufacturing, and Regulatory Affairs teams to develop and execute regulatory strategies and support continued product approvals across global markets. Job Description The Regulatory Affairs Specialist will develop and execute medical device regulatory strategies supporting product development and lifecycle management activities. This individual will manage regulatory content and submission activities with limited supervision and work cross-functionally to support timely global product approvals. Responsibilities will include preparing and supporting new market applications, renewals, variations, amendments, and other regulatory submissions , as well as managing regulatory activities associated with manufacturing changes for EU Class IIb medical devices . The Regulatory Affairs Specialist will represent RA Device on product development and lifecycle management teams , providing regulatory guidance and collaborating with R&D, Operations, Engineering, and Manufacturing stakeholders. Additional responsibilities include reviewing and approving engineering studies, validation protocols and reports, and manufacturing changes , coordinating responses to Health Authority questions, and maintaining compliance with applicable global medical device regulations, including EU MDR 2017/745 . The ideal candidate will have demonstrated success taking international medical device regulatory activities from authoring and submission through Health Authority approval , with the ability to independently manage multiple regulatory priorities.

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