Manager, Regulatory Clinical Services

Job description

Why Hologic: Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence. What to expect: The Manager of Regulatory Clinical Services is responsible for the strategy, execution, and adequacy of clinical evaluation (CEP/CER), post‑market clinical follow‑up (PMCF), and periodic safety update report (PSUR and/or PMSR) activities for assigned medical devices across their lifecycle. This role ensures compliance with EU MDR and other global regulatory requirements and provides clinical and regulatory leadership to support product approvals, lifecycle management, and post‑market obligations. This position is remote: Clinical Evaluation Strategy & Oversight: Serve as clinical evaluation, post-market clinical follow-up, and periodic safety update report subject‑matter expert during Notified Body interactions, audits, and inspections. - Develop, maintain, and execute Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance with EU MDR Annex XIV and MEDDEV/MDCG guidance. - Ensure ongoi...