At a Glance
- Tasks: Ensure clinical safety and compliance for innovative contact lens products.
- Company: Join a leading global medical device company focused 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 real difference in healthcare.
- Qualifications: Licensed Ophthalmologist with experience in medical device vigilance and safety reporting.
The predicted salary is between 60000 - 80000 £ 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.
- Participate in or facilitate 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 Colchester employer: LennTech Search
LennTech is an exceptional employer for the Chief Medical Officer role, offering a dynamic work environment that prioritises clinical safety and regulatory compliance in the medical device sector. With a strong commitment to employee growth, we provide opportunities for professional development and collaboration with leading experts in ophthalmology, all while being part of a global team dedicated to enhancing patient safety and product integrity. Our culture fosters innovation and teamwork, making it a rewarding place to contribute to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Chief Medical Officer in Colchester
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups related to ophthalmology and medical devices. You never know who might have a lead on your dream job!
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back on showcasing your knowledge. Discuss recent trends in medical device safety or share insights from your experience with clinical trials. This will help you stand out as a candidate who knows their stuff!
✨Follow Up After Interviews
After an interview, drop a quick thank-you email to express your appreciation for the opportunity. It’s a simple gesture that keeps you fresh in their minds and shows your enthusiasm for the role.
✨Apply Through Our Website
Don’t forget to check out our website for job openings! Applying directly through us can give you an edge, as we’re always on the lookout for passionate candidates who fit our culture and values.
We think you need these skills to ace Chief Medical Officer in Colchester
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. We love seeing passion and clarity, so make sure to connect your experiences directly to the job requirements.
Showcase Your Communication Skills:Since excellent communication is key for this role, ensure your written application reflects that. We appreciate clear, concise language and proper use of medical terminology, so keep it professional yet approachable!
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we do at StudySmarter!
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 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 Medical Monitor, 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
At the end of the interview, don’t shy away from asking questions. Inquire about the company’s approach to clinical safety evaluation or how they handle post-market vigilance. This shows your enthusiasm for the role and helps you gauge if the company aligns with your values.
