Senior Regulatory Affairs Specialist – Multiple Locations

Smith+Nephew•Memphis, TN

2d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. This role is based in Memphis Tennessee and may also be in Andover Massachusetts, Fort Worth Texas or Pittsburgh Pennsylvania. As a Senior Regulatory Affairs Specialist, you will lead global regulatory strategies and submissions for our Orthopaedics portfolio, helping ensure that innovative medical devices reach patients safely and efficiently. This is an opportunity to take ownership of complex projects, influence key decisions and grow your expertise in a collaborative, purpose driven environment. What will you be doing? You will contribute to bringing orthopaedic innovations to patients by leading regulatory strategy and execution across global markets. Your responsibilities will include: Preparing and reviewing global regulatory submissions, including United States 510(k), United States Class III annual reports, United States PMA and HDE supplements, and European Union MDR technical documentation, while supporting regional colleagues with international submissions, registration updates and license renewals. Leading regulatory strategy and documentation development as the Regulatory Affairs representative on cross functional project teams, ensuring submissions support timely global product launch readiness. Developing and executing global regulatory strategies to support market expansion and product release for new and modified products. Managing and leading regulatory driven projects as assigned by management, ensuring clear planning, risk management and communication. Planning, leading and supporting internal audits and inspections by regulatory agencies to help maintain compliance with applicable requirements. Leading engagement with regulatory authorities, including coordinating communications and preparing responses to questions and requests for additional information. Serving as the Regulatory Affairs lead for engineering change requests, performing regulatory change assessments for design, labeling and manufacturing process changes, and maintaining domestic and international registrations accordingly. Developing and maintaining Standard Operating Procedures intended to support compliance with global regulatory requirements. Creating and authoring product labeling materials, including instructions for use, patient information and other documentation, in alignment with applicable regulatory expectations. Providing technical guidance, mentoring and regulatory training to Regulatory Affairs colleagues and cross functional partners, helping to build capability across the wider team.

Requirements

Bachelor’s degree, preferably in engineering, clinical, medical or scientific or technical discipline; RAPS certification or a Master’s degree in Regulatory Affairs is an advantage.
A minimum of 5 years of Regulatory Affairs experience or equivalent within the medical device industry, with proven success in regulatory submissions in key markets such as the United States and European Union, including experience with United States 510(k) submissions.
Demonstrated knowledge of medical device regulatory requirements, standards and guidance, including European Union MDR expectations.
Experience working effectively with large cross functional teams and diverse groups, with strong communication skills, the ability to influence stakeholders and the confidence to lead projects independently with some direction.
Experience with processes and Product Lifecycle Management systems, along with strong attention to detail, sound judgement and a proactive approach to solving problems and driving continuous improvement.

Nice To Haves

RAPS certification or a Master’s degree in Regulatory Affairs is an advantage.

Responsibilities

Preparing and reviewing global regulatory submissions, including United States 510(k), United States Class III annual reports, United States PMA and HDE supplements, and European Union MDR technical documentation, while supporting regional colleagues with international submissions, registration updates and license renewals.
Leading regulatory strategy and documentation development as the Regulatory Affairs representative on cross functional project teams, ensuring submissions support timely global product launch readiness.
Developing and executing global regulatory strategies to support market expansion and product release for new and modified products.
Managing and leading regulatory driven projects as assigned by management, ensuring clear planning, risk management and communication.
Planning, leading and supporting internal audits and inspections by regulatory agencies to help maintain compliance with applicable requirements.
Leading engagement with regulatory authorities, including coordinating communications and preparing responses to questions and requests for additional information.
Serving as the Regulatory Affairs lead for engineering change requests, performing regulatory change assessments for design, labeling and manufacturing process changes, and maintaining domestic and international registrations accordingly.
Developing and maintaining Standard Operating Procedures intended to support compliance with global regulatory requirements.
Creating and authoring product labeling materials, including instructions for use, patient information and other documentation, in alignment with applicable regulatory expectations.
Providing technical guidance, mentoring and regulatory training to Regulatory Affairs colleagues and cross functional partners, helping to build capability across the wider team.

Benefits

competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP
401k Matching Program
401k Plus Program
Discounted Stock Options
Tuition Reimbursement
Flexible Personal/Vacation Time Off
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
Hands-On, Team-Customized, Mentorship
Discounts on fitness clubs, travel and more!