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

Key Responsibilities

• 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 Clinical Affairs and RA with focus 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.

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.

Benefits

• 120K - 150K base salary plus 15% annual corporate bonus target.
• Competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits.
• Tuition reimbursement, parental and adoption leave.

About the Role

• Bridge Clinical Affairs and U.S. Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards.
• 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.

Skills

• 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.

Benefits

• Comprehensive medical benefits.
• Tuition reimbursement, parental and adoption leave.