LennTech are partnering with a global medical device client who are seeking a licensed Ophthalmologist to support clinical safety evaluation, post‑market vigilance, and device risk management for its diverse contact lens portfolio.

Job Summary

The Medical Monitor / Medical Vigilance Officer / Medical Safety Officer will provide expert ophthalmic assessment of adverse events, support regulatory compliance for UK/EU/global vigilance obligations and enhance both pre‑market & post‑market clinical evidence by contributing clinical insight into complaint trends, safety signals, and product investigations. Ultimately, ensuring the safety and integrity of clinical trials and global regulatory safety compliance.

Your responsibilities will include:

• Serve as Medical Monitor for pre‑market and post‑market clinical trial activities to ensure safety compliance with protocols, ICH‑GCP, and regulatory requirements (e.g. FDA, EU‑MDR, ISO etc.).
• Review adverse event (AE) submissions for completeness, clarity, and appropriateness of severity and relatedness classification in a timely fashion to ensure compliance with reporting timelines.
• Serve as the primary medical contact for internal and external investigators and supporting personnel.
• Report Serious Adverse Events (SAEs) and Unanticipated Serious Adverse Device Effects (USADEs) to Regulatory Affairs (RA) and the relevant notified bodies, as required, and within required timeframes.
• Perform monthly review of pre‑market AEs with RA.
• Generate monthly KPI reports for distribution to RA and Quality Assurance (QA) functions for pre‑market studies.
• Contribute to benefit–risk assessments and documentation for product investigations and CAPA activities (as needed).
• Support clinical assessments for risk management files and technical documentation.
• Work with RA and QA to review global complaints, AEs and failure rates
• Serve as SME for protocol, investigator brochure, study reports, etc. relative to safety endpoints.
• Provide safety input into Product Hazard assessments and evaluations
• Support R&D QA during audits for inquiries relating to AE and Product Complaint reporting.
• Participating in or facilitating Data Safety Monitoring Board (DSMB) reviews
• Collaborate with RA on review and assessment of documents of external origin (DOEO) and relevance to ongoing clinical activities.

Knowledge, Skills and Experience:

• Experience with medical device vigilance, safety reporting and or Health Hazard Evaluations
• Understand standardized medical coding, GCP, ISO and regulatory reporting requirements
• Ability to manage multiple projects and adjust to changing priorities
• Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology
• Optometry or ophthalmology background/training

Experience/Education:

• Licensed Ophthalmologist (GMC‑registered).
• At least 3 years of experience with pharmacovigilance, regulatory affairs or medical monitoring
• Experience in contact lens or medical device industry preferred