Regulatory Affairs Specialist

Smith+Nephew

Regulatory Affairs Specialist at Smith+Nephew designing and manufacturing technology. Preparing regulatory submissions and ensuring compliance for medical devices with international standards.

Posted 5/6/2026full-timeMemphis • Tennessee • 🇺🇸 United StatesJuniorMid-Level💰 $74,250 - $128,750 per yearWebsite

About the role

Key responsibilities & impact

Preparing global regulatory submissions including US 510(k) and EU technical documentation for new and modified medical devices
Partnering closely with cross functional project teams to develop regulatory strategies that support product launch timelines
Supporting international regulatory submissions in collaboration with regional regulatory colleagues
Maintaining up to date knowledge of global regulations, standards, guidance documents and country specific requirements
Completing regulatory change assessments for design, labeling and manufacturing changes to ensure ongoing compliance
Supporting internal and regulatory authority audits and engaging directly with regulatory agencies when required
Reviewing product labeling and contributing to the development and maintenance of regulatory SOPs

Requirements

What you’ll need

Bachelor’s degree or equivalent experience in a scientific or technical discipline
Minimum of 2 years of regulatory affairs experience within the medical device industry
Working knowledge of global medical device regulations, standards and guidance
Strong communication and technical writing skills with the ability to collaborate across diverse teams
A proactive, analytical mindset with the ability to manage multiple priorities in a fast paced environment

Benefits

Comp & perks

medical, dental, and vision coverage
401k
tuition reimbursement
medical leave programs
parental leave
generous PTO
paid company holidays annually
8 hours of Volunteer time
wellness offerings such as EAP

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsUS 510(k)EU technical documentationregulatory change assessmentscompliancetechnical writingregulatory strategiesproduct labelingregulatory SOPs

Soft Skills

communicationcollaborationanalytical mindsetproactiveability to manage multiple prioritiescross-functional teamwork

Certifications

Bachelor’s degree