Regulatory Affairs Specialist

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. Are you motivated by navigating complex regulatory landscapes and helping innovative medical technologies reach patients worldwide? As a Regulatory Affairs Specialist, you will play a key role in supporting global regulatory submissions and maintaining compliance across markets. This is an exciting opportunity to work in a collaborative, fast paced environment where your expertise directly supports successful product launches.

Requirements

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

Responsibilities

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