Lead, Evidence Analysis, Evaluation & Communications (EAEC) - ENT (Austin or Fort Worth, TX)

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

Are you passionate about translating clinical evidence into strategic impact? Join us in a pivotal role where your expertise in evidence analysis, regulatory evaluation, and scientific communication will shape the future of ENT technologies. This is your opportunity to lead cross-functional initiatives that drive innovation, compliance, and market success.

What will you be doing?

• 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

What will you need to be successful?

• 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)

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement

• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.