Clinical Regulatory Specialist

To support the development of clinical evaluation and post-market follow-up documentation, the full-time Global Clinical Regulatory Specialist will author Clinical Evaluation Plans, Reports, and Systematic Literature Reviews, collaborating with cross-functional teams and managing data collection and appraisal processes, while working in Lakewood, CO or remotely. Key responsibilities Lead the development of Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) documentation by coordinating with various stakeholders Conduct systematic literature searches and review published literature to assess the safety and performance of products Manage document reviews and approvals for clinical evaluation and PMCF documents, ensuring compliance with regulatory requirements Required qualifications A graduate degree (e.g., MS, PhD) in a scientific, biological, or medical science discipline or equivalent experience Minimum of 5 years of experience in clinical evaluation reporting or related regulatory roles within the medical device or pharmaceutical industry Strong understanding of clinical research methodologies and regulatory processes, including CE Marking and GCP procedures Proven experience in medical writing and systematic review methodologies Ability to collaborate effectively across multidisciplinary teams and manage multiple projects simultaneously