Sr. Mgr., Regulatory Affairs; RA & Clinical Affairs; Evident MIS

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

Company:
Evident

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 incumbent serves as both a hands‑on clinical program leader and a regulatory compliance focal point for U.S. operations.

• 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.

  Mentor junior clinical and RA team members.

  Promote collaboration, accountability, and quality culture across regional teams.

  Balance strategic oversight with direct execution as needed.

• 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.

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

U.S.

-based (East Coast preferred). Remote work possible; travel as required for clinical and regulatory activities.

120 K – 130 K base salary plus 15 % annual corporate bonus target.

Competitive salary, 401(k) program, annual bonus program, comprehensive medical benefits, tuition reimbursement, parental and adoption leave.

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