Architecture Specialist 4
Smith+Nephew
Summary
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.
Job description
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 offs, 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%.
Requirements
- Bachelor's degree or above in a business or information science discipline
- Typically 10 years of experience working within Regulatory, Quality or Clinical environments
- Extensive solution architecture and systems design experience
- Responsibility for complex solutions, architecture standards, data modelling, technical integrity and regulatory requirements
- Experience with cloud based technologies and methodologies
- Experience with on premise technologies
- Experience with Agile project methodologies and practices
- Strong stakeholder management skills
- Strong requirements management skills
- Strong communication skills
- Ability to provide specialist technical guidance across complex initiatives
- Ability to work in an office and meeting based environment
- Occasional international travel of less than 25%
Benefits
- 401(k) Matching
- 401(k) Plus Program
- Discounted Stock Purchase Plan
- Tuition Reimbursement
- Flexible PTO
- Paid Holidays
- Flex Holidays
- Paid Community Service Day
- Medical, Dental & Vision
- Health Savings Account
- Employee Assistance Program
- Parental Leave
- Fertility and Adoption Assistance
- Fitness Club Discounts
- Hybrid Work Model
Company overview
Smith+Nephew is a global portfolio medical technology company with a rich history dating back to 1856, originally founded as a chemist shop in Hull, UK. The company specializes in the repair, regeneration, and replacement of soft and hard tissue through innovative medical devices and technologies. Operating through three core business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management—Smith+Nephew serves healthcare professionals and patients in over 100 countries worldwide. With approximately 18,000 employees, the company generated annual sales of $5.5 billion in 2023 and is listed on both the London Stock Exchange (FTSE100) and New York Stock Exchange. Their product portfolio includes joint replacement systems, robotics-assisted surgical platforms, sports medicine implants, advanced wound care solutions, and ENT technologies. The company is pioneering new frontiers in medical technology, including Spatial Surgery systems that integrate augmented reality and real-time data processing for enhanced surgical precision. Smith+Nephew's mission centers on their "Life Unlimited" purpose, aiming to restore patients' bodies and self-belief through technological innovation that removes limitations on living.