Principal Specialist Regulatory Affairs, Selution (Irvine, CA or Remote)

About the position Responsibilities • Lead regulatory strategy development and execution for PMA submissions, ensuring compliance with FDA regulations and guidance. • Collaborate cross-functionally with R&D, Quality Assurance, and Clinical teams to support the development of combination products and medical devices. • Prepare and submit regulatory documents, including PMA applications, with emphasis on clinical module. • Direct and support interactions with regulatory agencies and provide timely responses to inquiries. • Stay current on industry trends, regulatory changes, and best practices to inform company strategy and ensure compliance. • Provide training and guidance to junior regulatory staff on regulatory requirements and processes. • Develop and maintain regulatory affairs policies and procedures to enhance operational efficiency. • Help manage FDA IDE/PMA clinical reports/modules and post-approval clinical study activities and be involved in clinical evaluation processes. • Interpret clinical evidence in the context of applicable regulations, standards, and guidelines (e.g., FDA guidance, MEDDEV 2.7/1, MDR). • Support literature reviews and research to stay abreast of industry trends, competitor products, and emerging technologies. Requirements • Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred. • 8-10 years of experience in regulatory affairs within the medical device industry, with a strong focus on PMA submissions. • In-depth knowledge and understanding of FDA submissions for IDE and PMA process. • Previous experience with authoring clinical modules for FDA submissions. • Knowledge and understanding of clinical evaluation documentation to MEDDEV 2.7/1 guidelines. • Previous experience in medical writing, preferably within the device-drug combination devices. • Previous experience in Post Market Surveillance activities (PMS) and Post Market Clinical Follow-up activities (PMCF). • Expert knowledge of regulatory requirements and guidance documents for medical devices with FDA regulations (e.g., IDE, PMA) and familiarity with international standards (e.g., ISO 13485, EU MDR, MEDDEV 2.7/1, ISO14155, MDCG). • Excellent communication, negotiation, and interpersonal skills. • Strong analytical and problem-solving abilities, with a proactive approach to regulatory challenges. • Ability to work independently and as part of a team in a fast-paced environment. Nice-to-haves • Experience with combination products is highly desirable. • Experience in clinical research is highly desirable. Benefits • 401(k) • Medical, Dental and Vision Insurance • Life insurance • Paid time off Apply tot his job Apply tot his job