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!