Lead, Evidence Analysis, Evaluation & Communications (EAEC) – ENT
At Smith+Neu we design technology that extends living limits. In this pivotal role you translate clinical evidence into strategic impact, leading cross‑functional initiatives that drive innovation, compliance and market success.
Responsibilities
* Lead the development of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs) and Summary of Safety and Clinical Performance (SSCPs) in compliance with EU MDR and global standards.
* Conduct systematic literature reviews and data extraction to support clinical evaluations and regulatory submissions.
* Act as subject matter expert during audits and regulatory reviews, providing strategic input and supporting new product development decisions.
* Perform critical appraisal and synthesis of clinical and scientific data to support product claims and strategic decision‑making.
* Manage product claims and ensure alignment with clinical evidence and regulatory standards.
* Translate complex data into accessible formats such as infographics, summaries and training materials.
* Develop and lead evidence communication strategies for priority brands.
* Collaborate with internal teams and external partners to ensure alignment with business strategy and regulatory requirements.
Qualifications
* Minimum of 5 years’ commercial experience in medical device or pharmaceutical sectors, or 8 years combined academic and industry experience.
* Proven ability to conduct literature reviews and analyze clinical and scientific data.
* Expertise in authoring regulatory documents aligned with EU MDR and related frameworks.
* Experience developing promotional and educational materials aligned with clinical evidence and strategy.
* Strong scientific writing, data analysis and project management skills.
* Degree in biomedical sciences or clinical discipline (PhD preferred).
Benefits & Perks
* Generous annual bonus and pension schemes.
* Hybrid working model – flexible vacation, time off and paid volunteering hours.
* Private health and dental plans, healthcare cash plans and life assurance.
* Discounts on gyms, fitness clubs and salary sacrifice bicycle and car schemes.
* Hands‑on, team‑customised mentorship and extra employee discounts.
Inclusion & Belonging
Committed to welcoming, celebrating and thriving on inclusion and belonging. Our strongest investments are in our people and the patients we serve.
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