Clinical Evaluation Expert
Remote (With one day per week in the Dover office for the first six months. Must be prepared to travel)
About Us
Medical Engineering Technologies (MET) is a medical device testing specialist organisation that has been supporting device developers and manufacturers for over 20 years.
Partnering with our customers, we have successfully delivered medical devices in over 20 countries across Europe, America, Africa, Asia and Australia, boasting ISO 17025 accreditation and offering an arrange of testing services from mechanical performance to biocompatibility and chemical characterisation.
We are now looking for a Clinical Evaluation Expert to join our Consultancy team in a home-based capacity anywhere within the UK with regular travel to Dover.
Your Rewards
- Salary of £35,000 - £60,000 Dependent on Experience with Clinical Evaluation Plans
This is the perfect role for a medical device professional with a solid grounding in the life sciences and plenty of experience in clinical evaluations to advance their career with our leading global company.
With a strong portfolio of successful devices across multiple continents and an expert team to play a key role in, we will enable you to further your expertise and operate at the forefront of the sector.
We have a strong set of values that govern everything we do and support our successes, we do what is right, we have ownership, we continually improve, we are our community and we work together. If these resonate with you, read on and apply today.
Your Role
As a Clinical Evaluation Expert, reporting to the Consultancy Department Manager, you will be responsible for providing leadership and support for the development and creation of Clinical, Scientific, and Regulatory documents that support clinical and combination device development.
You will undertake clinical evaluations and periodic product safety assessments of medical devices. This involves the creation of plans and compiling findings from the literature, clinical studies and market surveillance. Generating reports that will describe the safety and performance of the device, you will also assess the benefit/risk of our products to comply with medical device regulations.
Participating in the development and generation of Clinical Evaluation Plans and Reports, you will contribute as the expert on clinical regulations and guidance to help us develop the strategy and ensure the final execution is in line with expectations.
You will also participate in Post-Market Clinical Follow-up (PMCF) planning, development and execution and perform comprehensive, systematic, documented literature reviews using various resources. Additionally, you will analyse available clinical evidence to evaluate the safety and performance of the subject device under evaluation.
As part of your role, you will be expected to travel to Dover once or twice per month for meetings.
Your role will also involve:
- Conducting literature reviews
- Writing Clinical Evaluation Plans and Reports (CER), analysing product complaints and trends and collecting and analysing feedback from various sources to support global CER documentation
- Providing critical expertise and guidance for cross-functional teams from the planning to execution phases to ensure the clinical documents meet the highest standards and provide the necessary data to support marketing applications
- Clinical data collection, clinical evaluation plans and reports
- Documenting regulatory submissions
About You
To be considered as a Clinical Evaluation Expert, you will need:
- Experience of clinical evaluation plans, UK and EU MDR, post-market surveillance and gap analysis
- A background in the medical device industry
- An understanding of clinical data such as Medical Device clinical outcomes and complaints
- Knowledge and understanding of proposed and current global regulations and guidance and the ability to relay the impact of such regulations and guidance internally
- Knowledge of clinical research and regulatory requirements
- Excellent communication skills in English, both verbal and written
- A Life Sciences degree (BSc, MSc or PhD) with the ability to read and process/analyse scientific literature
Applications will only be accepted from individuals who are eligible to live and work within the UK.
The closing date for this role is the 31st July 2024.
Other organisations may call this role Clinical Evaluation Specialist, Medical Devices Technologist, Medical Engineer, Medical Device Engineer. Biomedical Engineer, or Clinical Engineering Specialist.
We're all about celebrating diversity and creating a workplace where everyone can bring their A-game! Join us on our fantastic journey to assemble an awesome team, regardless of background. Be yourself, and let's achieve greatness together!
Ready for an amazing career? Select the apply button and join us now as a Clinical Evaluation Expert! And hey, we're committed to making our recruitment process fully inclusive and accessible, so if you need anything, just give us a shout.
MET Ltd is an equal opportunities employer.
This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.
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Do you have a background in the medical device industry?
Looking to advance your career with a leader in clinical and combination device testing?
Medical Engineering Technologies (MET) are looking for a new Clinical Evaluation Expert to join their team and support the delivery of device evaluation processes.
This is a home working position with monthly travel to Dover, earning £35,000 - £60,000 and providing ample opportunity to develop and enhance your career.
Want to learn more? Select Apply below.