Clinical Regulatory Support Specialist

Job Summary

A company is looking for a Global Clinical Regulatory Support Specialist.

Key Responsibilities

• Lead the development of Clinical Evaluation Reports (CERs) and Post-market Clinical Follow-up (PMCF) documentation by collaborating with various stakeholders
• Conduct systematic literature searches and review published literature to assess safety and performance of products
• Manage document reviews, reconcile comments, and facilitate the finalization of clinical evaluation documents

Required Qualifications

• A graduate degree (e.g., MS, PhD) in a scientific, biological, or medical science discipline or equivalent experience
• Five years of experience in clinical evaluation reporting or regulatory roles within the medical device/pharmaceutical industry
• Knowledge of research methodology, information management, and relevant regulatory requirements
• Experience with systematic reviews and clinical data appraisal
• Understanding of clinical research and regulatory guidelines