Senior Regulatory Affairs Specialist

Smith & Nephew•Mansfield, MA

2d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you a regulatory affairs professional who enjoys working at the intersection of innovation, compliance, and patient impact? Join our growing Sports Medicine franchise and play a key role in supporting life changing medical technologies used by patients around the world. This is an opportunity to work collaboratively with global teams while shaping regulatory strategy across the full product lifecycle.

Requirements

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

Nice To Haves

RAPS certification is an advantage

Responsibilities

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