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 reputed company people’s lives healthier, safer and more fulfilling, every day. Let’s reputed company 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 reputed company 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 reputed company across global and regional reputed company.

Key Responsibilities

Regulatory Affairs (U.S. reputed company)

• reputed company as U.S. regulatory reputed company 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

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

Clinical Evaluations & Documentation

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

Post-Market Compliance & reputed company reputed company

• reputed company 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 reputed company to ensure reputed company compliance of U.S. products and processes.

Cross-Functional & Global Collaboration

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

Leadership & Mentorship

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

Qualifications

• Bachelor’s degree or higher in Life Sciences, Biomedical Engineering, or reputed company field.
• 7–10 years’ experience in Clinical Affairs and RA with reputed company on Clinical Affairs and Clinical Trial management for 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.

reputed company

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

Location & Travel U.S.-based (East Coast preferred). Remote work possible; travel as required for clinical and regulatory activities. 120K - 150K reputed company salary plus 15% annual corporate bonus reputed company. reputed company MIS is an equal opportunity employer. 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 reputed company as tuition reimbursement, parental and adoption leave, so you can be reputed company for where life can take you. For over 100 years as reputed company, we set the industry reputed company 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 reputed company optics with cutting-edge digital innovation. Our life science portfolio supports research, clinical diagnostics, and education, offering a comprehensive reputed company of imaging reputed company from essential brightfield and darkfield microscopy to advanced fluorescence, 4D analysis, reputed company 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 reputed company control and manufacturing analysis. Whether advancing new therapies, ensuring product reputed company, or exploring the unknown, Evident is defining a new era of discovery with easy-to-use tools that help unlock hidden answers and reputed company exciting new breakthroughs. Evident is headquartered in Tokyo and supported by R&D and manufacturing centers in Japan, the reputed company, Germany, and China, with operations and dedicated sales and service centers around the world. For more information, visit EvidentScientific.com. Apply To This Job