At a Glance
- Tasks: Ensure clinical safety and compliance for innovative contact lens products.
- Company: Join a global leader in medical devices with a focus on eye care.
- Benefits: Competitive salary, professional development, and a chance to impact patient safety.
- Other info: Dynamic role with opportunities for growth in a collaborative environment.
- Why this job: Be at the forefront of ophthalmic safety and make a difference in healthcare.
- Qualifications: Licensed Ophthalmologist with experience in medical device vigilance and safety reporting.
The predicted salary is between 80000 - 100000 £ per year.
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.
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.
Chief Medical Officer in Southampton employer: LennTech Search
LennTech is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration in the medical device sector. With a strong commitment to employee development, we provide ample opportunities for professional growth and advancement, alongside a comprehensive benefits package that prioritises work-life balance. Located in a vibrant area, our team enjoys a supportive culture that values expertise and encourages contributions to enhance patient safety and clinical excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Chief Medical Officer in Southampton
✨Tip Number 1
Network like a pro! Reach out to your contacts in the medical device industry, especially those who work with ophthalmology. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory compliance and safety reporting. We want you to be able to discuss your experience confidently and show how it aligns with the role of Medical Monitor.
✨Tip Number 3
Don’t forget to showcase your communication skills! Whether it's during an interview or networking event, being able to articulate complex medical concepts clearly is key. Practice explaining your past experiences in simple terms.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our platform.
We think you need these skills to ace Chief Medical Officer in Southampton
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in ophthalmology and medical device vigilance. We want to see how your background aligns with the responsibilities listed in the job description, so don’t hold back on showcasing relevant skills!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Chief Medical Officer role. Be sure to mention specific experiences that relate to clinical safety evaluation and regulatory compliance.
Showcase Your Communication Skills:Since excellent communication is key for this role, make sure your written application reflects that. Use clear, concise language and appropriate medical terminology to demonstrate your expertise and professionalism.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at LennTech Search
✨Know Your Stuff
Make sure you brush up on your knowledge of ophthalmology and the specific medical device regulations. Familiarise yourself with ICH-GCP, FDA, and EU-MDR guidelines, as well as any recent developments in contact lens safety. This will show that you're not just qualified but also genuinely interested in the role.
✨Prepare for Scenario Questions
Expect to be asked about how you would handle specific adverse events or regulatory compliance scenarios. Think through some examples from your past experience where you successfully managed similar situations. This will help you demonstrate your problem-solving skills and expertise.
✨Showcase Your Communication Skills
As a Chief Medical Officer, you'll need to communicate complex medical information clearly. Practice explaining technical concepts in simple terms, as you might have to do this with non-medical stakeholders. Highlight any experience you have in collaborating with cross-functional teams.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to clinical safety evaluation and how they manage post-market vigilance. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your values and career goals.
