Architecture Specialist 4

USA - Smith & Nephew, Inc.; Memphis (TN); On-site; USD 140,000 - 190,000; Full time

Job summary

Smith+ Nephew in Memphis seeks an RAQA/Clinical IT Solutions Architect to drive the architecture of solutions supporting regulatory, quality and clinical needs. You will balance cloud and on‑prem technologies, define architecture standards, and work with stakeholders to translate complex requirements into compliant, scalable IT solutions.

The role requires extensive experience in solution architecture, data modelling and regulatory requirements, with a strong emphasis on cloud and on-prem

Qualifications

• Bachelor’s degree or above in a business or information science discipline with typically 10 years of experience in Regulatory, Quality or Clinical environments.
• Extensive solution architecture and systems design experience including data modelling, regulatory requirements and architectural standards.
• Experience with cloud-based and on-premise technologies, and agile methodologies (SAFe/CSM desired).

Responsibilities

• Lead architecture of solutions supporting clinical studies, Regulatory Affairs, Quality Assurance and Clinical systems.
• Design complex solutions across cloud and on‑prem technologies, balancing business needs with quality, security and performance.
• Define architecture strategies, standards and components while ensuring technical integrity and regulatory compliance.
• Partner with stakeholders and project teams to define, prioritize and manage requirements.
• Evaluate emerging clinical and digital technologies to improve regulatory, quality and clinical processes.
• Review designs, assess risks and ensure outputs meet service acceptance criteria.
• Provide advanced support for Regulatory Affairs, Quality Assurance and Clinical enterprise software and optimize global support models.

Skills

Architecture design

Cloud technologies

Agile methodologies

Stakeholder management

Regulatory/Quality/Clinical domain

SAFe/CSM certification

Education

Bachelor's degree or higher in business or information science

Tools

SAFe

Job description

Life. Unlimited. At Smith+ Nephew we design and manufacture technology that takes the limits off living. Before applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization.

RAQA/Clinical IT Solutions Architect

Are you an experienced solutions architect passionate about connecting technology with Regulatory Affairs, Quality Assurance and Clinical needs? Based in Memphis, Tennessee, this role offers the opportunity to shape complex IT solutions that help accelerate delivery to market while supporting regulatory compliance, quality and future business needs.

What will you be doing?

• Lead the architecture of solutions supporting clinical studies and Regulatory Affairs, Quality Assurance and Clinical systems, ensuring alignment with regulatory requirements and Smith+ Nephew IT architecture standards.
• Design complex solutions across cloud based and on premise technologies, balancing business requirements, quality, performance, security and technical constraints.
• Define architecture strategies, standards and components while overseeing technical integrity and architectural compliance throughout solution delivery.
• Partner with business stakeholders, process owners, technical teams and project teams to define, prioritize and manage requirements.
• Evaluate emerging clinical and digital technologies to identify opportunities that improve regulatory, quality and clinical processes.
• Review solution and system designs, assess risks and trade off, and ensure outputs meet agreed service acceptance criteria.
• Provide advanced support for Regulatory Affairs, Quality Assurance and Clinical enterprise software, while identifying opportunities to shift support to efficient global models.

What will you need to be successful?

• Bachelor’s degree or above in a business or information science discipline, with typically 10 years of experience working within Regulatory, Quality or Clinical environments.
• Extensive solution architecture and systems design experience, including responsibility for complex solutions, architecture standards, data modelling, technical integrity and regulatory requirements.
• Experience working with cloud based technologies and methodologies, along with on premise technologies.
• Experience with Agile project methodologies and practices.
• SAFe or Agile Certified ScrumMaster certification is desired.
• Strong stakeholder management, requirements management and communication skills, with the ability to provide specialist technical guidance across complex initiatives.
• Ability to work in an office and meeting based environment, with occasional international travel of less than 25%.

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.

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!

Equal Employment Opportunity

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.

Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited, life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+ Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+ Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.