Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs (Evident MIS)

Are you looking for a company that cares about people’s lives and health, including yours? At EVIDENT, we help make people’s lives healthier, safer and more fulfilling, every day. Let’s inspire healthier lives, together. This role bridges Clinical Affairs and U.S. Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards. The position serves as both a hands-on clinical program leader and a regulatory compliance focal point for U.S. operations, supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs – Clinical Business, the incumbent ensures scientific rigor, regulatory compliance, and operational excellence across global and regional projects.

Key Responsibilities

Regulatory Affairs (U.S. Focus)

• Act as U.S. regulatory lead for clinical and medical device products, overseeing FDA submissions (510(k), PMA) and communications.
• Ensure ongoing compliance with 21 CFR Part 820, ISO 13485, and MDSAP requirements.
• Support QMS implementation, internal/external audits, and post-market surveillance in alignment with corporate QA.
• Liaise with FDA and other authorities during inspections and submissions.

Clinical Study Program Leadership

• Lead global clinical studies from concept to reporting; manage CROs, labs, and clinical sites.
• Define study objectives aligned with regulatory and business goals.
• Maintain inspection readiness and ensure data integrity and GCP compliance.

Clinical Evaluations & Documentation

• Develop and maintain Clinical Evaluation Plans (CEP) and Reports (CER) per EU IVDR/MDR and FDA.
• Lead literature reviews, risk–benefit analyses, and clinical evidence synthesis.
• Ensure alignment between clinical data, labeling, and regulatory claims.

Post-Market Compliance & Quality Interface

• Oversee post-market clinical follow-up (PMCF) activities and complaint evaluation from a regulatory/clinical perspective.
• Support vigilance reporting, field actions, and regulatory submissions for changes or corrections.
• Collaborate with Quality to ensure continuous compliance of U.S. products and processes.

Cross-Functional & Global Collaboration

• Lead coordination between Clinical Affairs, U.S. regulatory operations, and Global RA teams to ensure consistent regulatory and clinical alignment.
• Align strategies and ensure consistency of technical documentation, labeling, and registration activities.
• Contribute to global regulatory strategy discussions, providing U.S. compliance insights.

Leadership & Mentorship

• Mentor junior clinical and RA team members.
• Promote collaboration, accountability, and quality culture across regional teams.
• Balance strategic oversight with direct execution as needed.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Biomedical Engineering, or related field.
• 7–10 years’ experience in Regulatory or Clinical Affairs (medical devices/IVD).
• Hands-on experience with FDA 510(k)/PMA submissions, clinical study design, and QMS implementation.
• Familiarity with ISO 14155, GCP, FDA 21 CFR 820, ISO 13485, EU MDR/IVDR.
• Strong project leadership and stakeholder management skills.
• Excellent written and verbal communication in English.

Mindset

• Hands-on, pragmatic, and compliance-oriented.
• Balances regulatory precision with operational agility.
• Proactive, collaborative, and motivated to enhance clinical and regulatory excellence.

Location & Travel U.S.-based (East Coast preferred). Remote work possible; travel as required for clinical and regulatory activities. 120K - 130K base salary plus 15% annual corporate bonus target #LI-Remote We realize work isn’t just a job to you. It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, parental and adoption leave, so you can be ready for where life can take you. For over 100 years as Olympus, we set the industry standard for optical precision in microscopy, helping the world see what was once out of view. Today, as Evident, we continue to help scientists, physicians, and engineers illuminate the unseen with advanced imaging solutions that combine renowned optics with cutting-edge digital innovation. Our life science portfolio supports research, clinical diagnostics, and education, offering a comprehensive range of imaging methods from essential brightfield and darkfield microscopy to advanced fluorescence, 4D analysis, and digital pathology. In industrial microscopy, we deliver precision and flexibility through laser scanning, digital, and semiconductor microscopes designed for tasks ranging from routine inspection to intricate quality control and manufacturing analysis. Whether advancing new therapies, ensuring product integrity, or exploring the unknown, Evident is defining a new era of discovery with easy-to-use tools that help unlock hidden answers and empower exciting new breakthroughs. Evident is headquartered in Tokyo and supported by R&D and manufacturing centers in Japan, the United States, Germany, and China, with operations and dedicated sales and service centers around the world. For more information, visit EvidentScientific.com.