Smith & Nephew-posted 2 months ago
Full-time • Entry Level
Hybrid • Memphis, TN
5,001-10,000 employees
Miscellaneous Manufacturing

At Smith+Nephew, we design and manufacture technology that takes the limits off living. We are looking for a Regulatory Affairs Specialist to join our team and drive regulatory strategies for our cutting-edge products. This role involves preparing global regulatory submissions for the orthopedic reconstruction device product portfolio, supporting sustaining activities for legacy products, and communicating with regulatory bodies. The successful candidate will work closely with project teams to ensure compliance with regulations and support international registrations.

  • Prepare global regulatory submissions (such as 510(k), PMA, MDR Technical Files, Annual Reports, etc.) for the orthopedic reconstruction device product portfolio.
  • Support business critical sustaining activities for the legacy orthopedic product portfolio, including regulatory impact assessments and associated re-registrations.
  • Work closely with project teams to develop regulatory strategies, testing requirements, and documentation for regulatory submissions.
  • Communicate with FDA and other regulatory bodies regarding submissions.
  • Support cross-functional projects through regulatory submission/compliance strategy documents and documentation reviews.
  • Support technical file and quality audits.
  • Maintain a working knowledge of existing and proposed regulations, standards, and guidance documents.
  • Review and approve change requests for design, manufacturing, and labeling changes.
  • Review package inserts, Surgical Techniques, and promotional materials for compliance.
  • Support International Registrations for the Ortho product portfolio.
  • Bachelor's or Master's degree in Regulatory Affairs or closely related field.
  • BA or BS in Business Administration, Life Science, nursing, medical technology or related field with 3 or more years of prior work experience in the regulated medical industry.
  • Minimum of 2 years of relevant regulatory experience in the medical device industry.
  • Knowledge of current US and EU regulations.
  • Ability to read, analyze, and interpret regulations and complex documents.
  • Ability to respond to inquiries from regulatory agencies.
  • Ability to write detailed technical regulatory submissions and reports.
  • Ability to effectively present information to employees, management, and regulatory agencies.
  • Proficiency in Microsoft Outlook, TEAMs, Word, Excel, PowerPoint.
  • Orthopedic device experience.
  • 401k Matching Program
  • 401k Plus Program
  • Discounted Stock Options
  • Tuition Reimbursement
  • PTO
  • Paid Holidays
  • Flex Holidays
  • Paid Community Service Day
  • Medical, Dental, Vision
  • Health Savings Account (Employer Contribution of $500+ annually)
  • Employee Assistance Program
  • Parental Leave
  • Fertility and Adoption Assistance Program
  • Hybrid Work Model
  • Hands-On, Team-Customized Training
  • Mentorship
  • Discounts on fitness clubs, travel and more
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