Sr. Clinical/Regulatory Affairs Specialist

Sr. Clinical/Regulatory Affairs Specialist Lead Clinical Studies. Drive Regulatory Success. Make a Global Impact. We're seeking a Sr. Clinical/Regulatory Affairs Specialist to manage all clinical study activities and regulatory submissions for global product market clearance. If you're passionate about driving clinical excellence, working cross-functionally, and supporting regulatory success, this role is for you. What You'll Do: Clinical Study Management Lead and collaborate with Cytek and CRO project teams to develop clinical study strategies aligned with product characteristics and intended use. Develop clinical study protocols, perform literature reviews, and analyze clinical and scientific evidence to support study designs. Oversee informed consent development, IRB approval, and investigator financial statements in collaboration with the CRO team. Work closely with biostatisticians on statistical plans, including sample size, statistical methods, and acceptance criteria. Coordinate and facilitate investigator meetings, adverse event reporting, and ensure compliance with the clinical study protocol. Manage the development of electronic data capture (EDC) systems and data management plans with the CRO data management team. Oversee site monitoring, audits, and data accuracy, ensuring clinical study protocols are followed. Regulatory Support Assist in the preparation of regulatory documents for 510(k), IVDR, and other global product market clearance and registration submissions. Collaborate with the regulatory affairs team to ensure timely submission of regulatory documents. Support FDA Q-submissions and assist with 510(k) and EU IVDR regulatory submissions. Cross-Functional Collaboration Work with KOLs to gather feedback on product use and align clinical study protocols. Act as the clinical area expert on project teams, contributing to assay development, data analysis, interpretation, and software feature evaluation. Conduct hands-on laboratory testing, data analysis, and troubleshooting to support clinical study design. What You Bring: BS, MS, or PhD in medical technology or a related field with at least 8 years of experience in the medical device or biotechnology industry. CLIA lab experience preferred. Proven experience in conducting clinical trials in the U.S. and EU, including experience with flow cytometry in clinical applications (immunodeficiency, leukemia, lymphoma). Expertise in developing clinical study protocols following GCP, GLP, and applicable regulatory requirements. Knowledge of CLIA, GLP, and GCP requirements, with hands-on experience in blood sample preparation and flow cytometry. Experience with statistical analysis and software development is a plus. Strong understanding of U.S. and EU regulatory requirements. Excellent verbal and written communication skills, with the ability to collaborate across functions in a fast-paced environment. Why Join Cytek? At Cytek, you're not just advancing clinical studies-you're playing a pivotal role in bringing cutting-edge technology to global markets. We value your expertise and provide a collaborative, dynamic environment where you can make a real difference. Impactful Role:

Shape clinical studies and regulatory strategies that will have a direct impact on product success. Professional Growth:

Grow your career in a fast-moving, innovative company. Competitive Rewards:

Enjoy competitive pay, great benefits, and an inclusive team culture. Cytek is an equal-opportunity employer.

We celebrate diversity and are committed to creating an inclusive environment. Ready to drive clinical and regulatory success? Apply now and make an impact!