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

Evident•Needham, MA

45d•$120,000 - $130,000•Remote

About The Position

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.

Requirements

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.

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.
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.
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.
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.
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.