Barrington James are exited to post a fantastic opportunity for one of our close clients. This company is a Orthopedic Medical Device manufacturer. They are backed by some serious investors the industry and are looking for future support within their regulatory. This opportunity is perfect for someone who is ambitious, independent and wants to play a key role in working on the most innovative projects.
Location: Europe (Flexible / Hybrid)
Reports to: VP Regulatory & Clinical Affairs
Requirements
* Define and implement the global clinical affairs and clinical evaluation strategy aligned with business objectives.
* Lead the development of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post-Market Clinical Follow-up (PMCF) strategies.
* Act as the clinical subject matter expert for orthopedic devices across internal and external forums.
Clinical Evidence Generation
* Oversee the design, execution, and management of clinical investigations (pre-market and post-market).
* Ensure clinical studies comply with applicable regulations (e.g., MDR, ISO 14155, GCP).
* Drive real-world evidence (RWE) generation and registry strategies.
Regulatory Support
* Partner with Regulatory Affairs to support CE marking and global market access.
* Provide clinical input into technical documentation and regulatory submissions.
* Interface with notified bodies and regulatory agencies during audits and submissions.
Post-Market Surveillance & PMCF
* Lead PMCF activities, including study design, data analysis, and reporting.
* Ensure alignment between PMS, risk management, and clinical evaluation.
* Monitor clinical performance and safety signals, recommending appropriate actions.
Cross-Functional Collaboration
* Work closely with R&D on clinical input for product development and usability.
* Support Marketing with clinically substantiated claims and scientific communication.
* Collaborate with Quality on risk management and vigilance activities.
* Build, lead, and mentor a high-performing clinical affairs team.
* Manage external vendors, CROs, and clinical consultants.
* Foster a culture of scientific rigor, compliance, and continuous improvement.
This truly is an exiting opportunity for someone to join an ambitious company who are continuing to impress the market with their ground-breaking studies.
The opportunity has understandably been incredibly popular. We encourage all interested candidates to apply immediately as it is likely that recruitment will close prematurely.
By clicking \"apply\" you will be sending your CV to Charlie Denton at Barrington James. Charlie is a specialist Medical Device, clinical affairs recruiter and will discuss the opportunity in detail with you, facilitate your application and will manage the process acting as a link between the company and yourself.
Please call +44 12 93 77 66 44 if you have any questions, alternatively you can reach Charlie on
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