Senior Regulatory Affairs Specialist

Smith+Nephew

Senior Regulatory Affairs Specialist at Smith+Nephew developing global regulatory strategies for medical devices. Collaborating with global teams while ensuring regulatory compliance and approvals throughout the product lifecycle.

Posted 5/24/2026full-timeMansfield • Massachusetts • 🇺🇸 United StatesSenior💰 $101,500 - $152,250 per yearWebsite

About the role

Key responsibilities & impact

Developing and executing global regulatory strategies for new and modified medical devices
Preparing and managing regulatory submissions to obtain and maintain global market approvals
Providing regulatory guidance to cross functional teams across product development, manufacturing, and compliance activities
Assessing product and manufacturing changes to ensure continued regulatory compliance throughout the product lifecycle
Acting as a company representative with global regulatory agencies, building and maintaining strong professional relationships
Supporting regulatory audits, advocacy initiatives, and regulatory intelligence activities
Developing and maintaining regulatory SOPs and providing training and mentoring to colleagues

Requirements

What you’ll need

Bachelor’s degree or equivalent experience, preferably in a scientific or technical discipline
5 or more years of Regulatory Affairs or related experience within the medical device industry
Proven experience managing FDA 510(k) submissions and EU MDR filings
Strong understanding of global regulatory requirements and medical device development processes
Excellent written and verbal communication skills, including technical writing
RAPS certification is an advantage

Benefits

Comp & perks

medical, dental, and vision coverage
401k
tuition reimbursement
medical leave programs
wellness offerings
401k Matching Program
401k Plus Program
Discounted Stock Options
Flexible Personal/Vacation Time Off
Paid Holidays
Flex Holidays
Paid Community Service Day
Employee Assistance Program
Parental Leave
Fertility and Adoption Assistance Program
Hands-On Training
Team-Customized Training
Mentorship
Discounts on fitness clubs, travel and more!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsFDA 510(k) submissionsEU MDR filingsregulatory complianceregulatory strategiesmedical device development processesregulatory SOPstechnical writing

Soft Skills

communication skillsinterpersonal skillsmentoringrelationship buildingcross-functional collaboration

Certifications

RAPS certification