At a Glance
- Tasks: Lead clinical evaluations and manage studies for innovative medical devices.
- Company: A leading medical device manufacturer with a focus on collaboration and innovation.
- Benefits: Remote work, continuous learning, and career progression opportunities.
- Other info: Join a dynamic team and work on global projects in a fast-paced environment.
- Why this job: Make a real impact in healthcare by ensuring medical devices are safe and effective.
- Qualifications: Experience in medical devices and knowledge of regulatory standards like ISO 13485.
The predicted salary is between 36000 - 60000 € per year.
A leading medical device manufacturer in South Wales is expanding its Regulatory & Clinical function and is seeking a Clinical Specialist to support clinical and post-market activities across a global product portfolio. This role sits at the centre of clinical strategy and delivery, supporting clinical evaluation, PMCF, and human factors engineering (HFE) activities within a highly regulated ISO 13485 and MDR 2017/745 environment. As a Clinical Specialist, you will collaborate closely with Regulatory Affairs, R&D, Quality, Manufacturing, and Marketing to ensure products remain clinically compliant and market-ready throughout their lifecycle.
Your responsibilities as a Clinical Specialist will include:
- Leading and supporting clinical evaluation and PMCF activities for medical devices from planning through to final reporting
- Managing clinical and HFE studies, ensuring delivery aligns with timelines, budgets, and regulatory expectations
- Providing clinical input across product development, design changes, manufacturing updates, and post-market surveillance
- Contributing to Clinical Evaluation Reports (CERs), PMCF plans, protocols, and technical documentation
- Interpreting global clinical and regulatory requirements, including ISO 13485, MDR 2017/745, FDA, ISO 14155, and ISO 14971
- Advising cross-functional teams on clinical data needs to support regulatory submissions and product claims
- Identifying clinical risks, usage challenges, and emerging issues, recommending practical mitigation strategies
- Supporting updates to clinical procedures, templates, and best practices
- Assisting with internal training on clinical and regulatory compliance topics
- Working with external partners and vendors where required to deliver clinical activities
To be successful as a Clinical Specialist, you will need:
- Experience within a medical devices organisation operating under ISO 13485
- Practical knowledge of MDR 2017/745 (and/or MDD), FDA requirements, and clinical standards such as ISO 14155 and ISO 14971
- Background in clinical evaluation, PMCF, or related regulatory clinical activities
- Strong written skills, with experience preparing clinical documentation and reports
- Ability to manage multiple priorities and contribute effectively to cross-functional project teams
- Confident communication skills, with the ability to influence and advise technical and non-technical stakeholders
- Experience working in fast-paced, regulated environments; international exposure is advantageous
Why join this opportunity?
- Work on globally distributed medical devices within a well-established regulatory framework
- Gain exposure to full lifecycle clinical strategy, PMCF, and HFE activities
- Join a collaborative, forward-thinking clinical and regulatory team
- The company supports continuous learning and career progression.
Please note, applicants must already have the right to work in the UK, as visa sponsorship is not available.
Clinical Specialist - Medical Devices | Remote employer: WALKER COLE INTERNATIONAL LTD
As a leading medical device manufacturer in South Wales, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to excel in their roles. Our commitment to continuous learning and career progression ensures that as a Clinical Specialist, you will have ample opportunities to grow professionally while contributing to impactful projects within a globally recognised regulatory framework. Join us to be part of a forward-thinking team dedicated to improving patient outcomes through cutting-edge medical technology.
Contact Detail:
WALKER COLE INTERNATIONAL LTD Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Specialist - Medical Devices | Remote
✨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 in landing that Clinical Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and MDR 2017/745. We recommend creating a cheat sheet of key points to discuss, so you can confidently showcase your expertise during those crucial conversations.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your skills, making your application stand out!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe this small gesture can keep you top of mind for hiring managers.
We think you need these skills to ace Clinical Specialist - Medical Devices | Remote
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Specialist role. Highlight your experience with ISO 13485 and MDR 2017/745, and don’t forget to showcase your strong written skills and any relevant clinical documentation you've prepared.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about medical devices and how your background in clinical evaluation and PMCF aligns with our needs. Keep it concise but impactful!
Showcase Your Team Spirit:We love collaboration at StudySmarter! In your application, mention any experiences where you worked closely with cross-functional teams. This will show us that you can effectively contribute to our dynamic environment.
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 makes the process smoother for everyone involved.
How to prepare for a job interview at WALKER COLE INTERNATIONAL LTD
✨Know Your Regulations
Familiarise yourself with ISO 13485, MDR 2017/745, and other relevant regulations before the interview. Being able to discuss these frameworks confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Clinical Experience
Prepare specific examples from your past roles where you've led clinical evaluations or PMCF activities. Highlight how you managed timelines and budgets while ensuring regulatory compliance, as this will demonstrate your hands-on experience in a highly regulated environment.
✨Communicate Clearly
Practice explaining complex clinical concepts in simple terms. You’ll likely need to communicate with both technical and non-technical stakeholders, so being able to articulate your thoughts clearly will be crucial for success in this role.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's clinical strategy and how they approach post-market surveillance. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your career goals.
