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For Companies At a Glance
- Tasks: Lead clinical evaluations and ensure compliance with EU regulations for medical devices.
- Company: Join a global leader in medical devices with a focus on innovation and patient safety.
- Benefits: Competitive salary, bonus, excellent pension, private medical insurance, and more.
- Other info: Dynamic role with opportunities for career growth and global impact.
- Why this job: Shape the future of healthcare while collaborating with experts in a supportive environment.
- Qualifications: Advanced degree in sciences or nursing and 3+ years in medical devices or pharmaceuticals.
The predicted salary is between 60000 - 80000 ÂŁ per year.
Location: Cirencester / Hybrid
About the Role
We are seeking an experienced Global Clinical Evaluation Lead to oversee the development and maintenance of clinical evaluation and post‑market clinical documentation across our global medical device portfolio. This is a pivotal role supporting regulatory compliance under EU MDR, global market access, and post‑market surveillance activities. The Global Clinical Evaluation Lead will be responsible for driving high‑quality Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), PMCF Plans and Reports, SSCPs, and associated literature activities, while coordinating a wide network of internal and external stakeholders. The role works closely with Product Core Teams (PCTs), clinical study teams, regulatory partners, and notified bodies, and acts as a key clinical subject‑matter expert across the business.
What you’ll do
- Lead and oversee the preparation, review, and finalisation of clinical evaluations and associated documentation in compliance with EU MDR requirements.
- Manage and collaborate closely with external clinical evaluation partners, including training, regular governance meetings, and timeline management.
- Prepare and coordinate responses to clinical review questions from Notified Bodies to support product submissions and certifications.
- Review and approve MDR deliverables including Clinical Evaluation Plans and Reports, PMCF Plans and PMCF Evaluation Reports, Literature searches and critical appraisals, Summary of Safety and Clinical Performance (SSCP).
- Contribute to global post‑market and reimbursement‑related activities across multiple markets, including EU, USA, Australia, Japan, and other international regions.
- Act as the clinical representative at annual Post‑Market Surveillance (PMS) meetings, providing expert input into PMS plans, PSURs, and benefit‑risk assessments.
- Participate in Product Core Team (PCT) meetings, advising on pre‑ and post‑market clinical strategy and regulatory requirements for new product registrations and renewals.
- Work closely with data management and clinical study teams to ensure timely delivery of clinical data inputs, escalating risks to timelines where necessary.
- Support interpretation and reporting of clinical investigation results (pre‑ and post‑market) for regulatory submissions and internal decision‑making.
- Serve as a clinical SME to internal teams including R&D, Marketing, and Regulatory Affairs, as well as external regulators when required.
About You
You will be a highly organised and detail‑driven clinical professional with strong regulatory knowledge and the ability to manage complex documentation across multiple products and markets.
What you’ll bring
- Advanced scientific degree (e.g. PhD, MSc), MD, or BS/BA in sciences or nursing, or equivalent combination of education and experience.
- Minimum 3 years’ industry experience within Medical Devices or Pharmaceuticals.
- Proven experience analysing, interpreting, and summarising clinical data for internal and external stakeholders.
- Strong understanding of European Medical Device Directive (MDD) and EU MDR.
- Experience conducting and reviewing literature searches and appraisals.
- Ability to interpret clinical study results and data analyses.
- Excellent written and verbal communication skills, with confidence engaging internal and external stakeholders.
- Strong problem‑solving skills, high attention to detail, and the ability to manage multiple priorities to deadline.
- Experience with PMCF and/or Post‑Market Surveillance (PMS) planning.
- Experience supporting regulatory submissions using Real‑World Evidence (RWE).
- Familiarity with global regulatory environments outside the EU.
Why Join Us
You’ll play a key role in shaping the clinical and regulatory strategy of a global medical device portfolio, working with cross‑functional experts in a collaborative and supportive environment that values scientific excellence and patient safety.
What's in it for you:
- A competitive salary and a discretionary annual bonus.
- Excellent pension – starts at 6%, going up to 9.7% after 18 months.
- Life assurance – Six times your basic salary.
- Private medical insurance with BUPA for you and your family.
- Free annual eye tests and flu vaccinations.
- Employee referral program where you can earn up to ÂŁ1,000 for each successful hire you recommend.
Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression or any other characteristic protected by federal, state or local laws.
Global Clinical Evaluation Specialist in Cirencester employer: Corin
Contact Detail:
Corin Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Clinical Evaluation Specialist in Cirencester
✨Tip Number 1
Network like a pro! Reach out to professionals in the medical device field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU MDR and clinical evaluation processes. We recommend practising common interview questions with a friend or even in front of the mirror to boost your confidence.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work, like Clinical Evaluation Reports or PMCF Plans, to demonstrate your skills during interviews. We want to see how you’ve made an impact in your past roles.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are genuinely interested in joining our team.
We think you need these skills to ace Global Clinical Evaluation Specialist in Cirencester
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Global Clinical Evaluation Specialist role. Highlight your relevant experience in clinical evaluations and regulatory compliance, as this will show us you understand what we're looking for.
Showcase Your Expertise: Don’t hold back on showcasing your knowledge of EU MDR and clinical evaluation processes. We want to see how your background aligns with our needs, so include specific examples of your past work that demonstrate your expertise.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless it's necessary. We appreciate a well-structured application that’s easy to read!
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 shows us you’re keen to join our team!
How to prepare for a job interview at Corin
✨Know Your Regulations
Make sure you brush up on the EU MDR and MDD regulations before your interview. Being able to discuss these in detail will show that you’re not just familiar with the requirements but also understand their implications for clinical evaluations.
✨Prepare Your Documentation Examples
Have specific examples of Clinical Evaluation Plans (CEPs) or Clinical Evaluation Reports (CERs) you've worked on ready to discuss. This will demonstrate your hands-on experience and ability to manage complex documentation effectively.
✨Engage with Stakeholders
Be prepared to talk about how you’ve collaborated with various stakeholders, including external partners and internal teams. Highlighting your communication skills and teamwork will be crucial, as this role involves a lot of coordination.
✨Showcase Your Problem-Solving Skills
Think of instances where you faced challenges in clinical evaluations or regulatory submissions and how you overcame them. Sharing these stories will illustrate your problem-solving abilities and attention to detail, which are key for this position.