Regular Affairs Specialist 2 (Memphis, TN)

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

In Regulatory Operations, you will be expected to lead and manage process improvement projects within our regulatory affairs organization. The role will be responsible for identifying, planning, and implementing process improvements to existing Regulatory Affairs workstreams to enhance efficiency, compliance, and overall performance.

What will you be doing?

• Lead and manage process improvement projects that impact the Regulatory Affairs Organization.

• Identify opportunities for process optimization and develop strategies to address them.

• Project Management:

  • Develop and manage detailed project schedules, including timelines, milestones, and deliverables.

  • Define project scope, goals, and deliverables that support business goals in collaboration with senior management and stakeholders.

  • Assign tasks and responsibilities to project team members and ensure timely completion of project deliverables.

  • Monitor project progress and make adjustments as necessary to ensure successful project completion.

  • Conduct regular project meetings to review progress, address issues, and ensure alignment with project goals.

  • Prepare and present project status reports to stakeholders and senior management.

  • Manage project risks and develop mitigation plans to address potential issues.

• Define requirements and user needs for business software systems

• Perform user acceptance testing on business software systems

• Collaborate with cross-functional teams to implement process changes and ensure compliance with regulatory requirements.

• Monitor and analyze process performance metrics to identify areas for improvement.

• Develop and maintain documentation for processes with standard operating procedures (SOPs), work instructions, and other training documentation.

• Provide training and support to Regulatory Organization and other cross functional teams on new processes and best practices.

• Ensure all regulatory processes are in compliance with local, national, and international regulations.

• Stay up-to-date with industry trends and regulatory changes to ensure continuous improvement.

What will you need to be successful?

• Education:

  • Bachelor's degree in Engineering, Life Science or related discipline preferred.

• Licenses/ Certifications:  RAC preferred.

• Experience:

  • Minimum 2 years of experience in regulatory affairs.

• Strong knowledge of regulatory requirements and industry standards.

  • Experience with regulatory submissions, change management, and compliance documentation.

  • Familiarity with regulatory software and tools (e.g., Veeva Vault, MasterControl).

  • Strong understanding of quality management systems (QMS) and Good Manufacturing Practices (GMP).

• Proven experience in managing process improvement projects.

  • Proficiency in process improvement methodologies (e.g., DMAIC, Lean, Six Sigma) is a plus.

• Excellent analytical and problem-solving skills.

• Strong communication, presentation, and interpersonal skills.

• Ability to work independently and as part of a team.

• Proficiency in data analysis and reporting tools (e.g., Excel, Tableau).

• Physical Demands:  Office work and some out-of-hours work will be required.

• Travel Requirements:  <5%

You. Unlimited

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

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future:  401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  
  Work/Life Balance:  PTO, 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)

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.