Flexible work from home options available.

• Serve as the IBMi Security Subject Matter Expert supporting Gaming Control Boards across all jurisdictions, external auditors, and internal audit teams. • Lead IBMi-related audit activities including SOX, PCI, and Gaming, ensuring timely remediation of findings across IT and property teams. • Design, implement, and manage IBMi security policies, standards, and procedures. • Support installation, configuration, upgrade, and administration of IBMi security tools and applications. • Monitor privileged access and investigate anomalous activity to mitigate security risks. • Apply the cybersecurity risk management framework to IBMi activities including vulnerability assessments, penetration testing, and security reviews. • Act as the IBMi security SME during incident response investigations • Develop and maintain IBMi security metrics and dashboards to support SOC and leadership reporting. • Analyze trends to identify systemic risks and improvement opportunities. • Partner with IT, property teams, and business stakeholders to align security solutions with business needs. • Provide mentorship, training, and guidance to junior security staff and non-security teams. • Contribute to cybersecurity and enterprise IT projects, including project planning and documentation.

• Lead and mature our governance, risk, and compliance program, aligned to NIST CSF 2.0 and our enterprise risk framework. • Own overall strategy and execution for data security (encryption, backups, DSPM, data lifecycle controls) in close partnership with Product, Engineering, and Infrastructure. • Serve as the primary infosec leader for PCI-DSS Level 1, HITRUST, SOC 2, and SOX ITGC coordination, ensuring evidence (including penetration testing), narratives, and controls are consistent and efficient. • Partner with product and engineering teams to embed security into software development lifecycles, roadmap planning, and quarterly business reviews. • Govern & guide Third Party Risk Management (TPRM) objectives. • Act as a matrixed leader, influencing teams you don’t directly manage while providing clear, actionable guidance to executives, developers, and staff. • Function as backup to the CISO for key decisions, stakeholders, and external meetings with customers, auditors, and regulators.

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about navigating regulatory landscapes? Do you thrive in fast-paced environments? We're looking for a Sr. Regulatory Affairs Specialist to join collaborative and energetic team working on regulatory submissions and compliance maintenance for Smith+Nephew. If you're ready to make an impact, apply now! What will you be doing? Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices. Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets. Review product labeling to ensure compliance with regulatory requirements. Other activities as assigned. What will you need to be successful? Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline (RAPS Certification or RA Master’s degree a plus). Minimum of 5 years’ regulatory experience or equivalent within the medical device industry or similar industries. Demonstrated experience with successful submissions in key markets such as US and EU. Demonstrated knowledge of regulatory requirements, standards and guidance for medical devices. Processes and Product Lifecycle Management Systems experience is required. Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc.) Ability to interpret and apply regulations, respond effectively to inquiries from regulatory agencies (both in writing and in person), and prepare detailed technical regulatory submissions, reports, and business correspondence. Strong interpersonal and communication skills, including technical writing, active listening, and clear verbal expression; proven ability to collaborate effectively with large cross-functional and diverse teams. Analytical and agile problem-solver with a high capacity for learning; self-motivated and solution-oriented, able to work independently and within teams, and adept at applying innovative approaches to complex challenges. Excellent organizational and time management skills, with the ability to prioritize and handle multiple demands in a dynamic, fast-paced environment. Applications will be accepted until February 15, 2026. **This position does not offe r visa sponsorship now or in the future** The anticipated base compensation range for this position is $95,500.00 - $167,500.00 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP. Travel Requirements: Up to 10%. 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 Options, 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! #LI-HYBRID #LI-SB2 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 L inkedIn 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.