Clinical Regulatory Specialist

Job Summary

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