Senior Regulatory Affairs Specialist

Smith & Nephew•Mansfield, MA

1d•Hybrid

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about bringing innovative medical technologies to market and helping improve patient outcomes around the world? As a Senior Regulatory Affairs Specialist, you will play a key role in developing regulatory strategies, securing global product approvals, and ensuring compliance throughout the product lifecycle. This is an exciting opportunity to collaborate with cross functional teams, influence product development, and help deliver meaningful healthcare solutions to patients worldwide. This position does not offer visa sponsorship now or in the future.

Requirements

Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline.
5+ years of Regulatory Affairs experience or related experience within the medical device or healthcare industry.
Strong knowledge of global regulatory requirements, medical products, product development processes, and design controls.
Proven experience managing regulatory submission activities and working with regulatory agencies.
Excellent analytical, problem solving, technical writing, communication, and project management skills.
Ability to effectively manage multiple priorities while collaborating across diverse teams.

Nice To Haves

RAPS Certification is a plus.

Responsibilities

Develop and execute regulatory strategies to support global product registrations, clearances, and approvals.
Provide regulatory guidance to product development and manufacturing teams throughout the product lifecycle.
Prepare, coordinate, and manage regulatory submissions to global health authorities.
Assess product and manufacturing changes for regulatory impact and continued compliance with global requirements.
Build and maintain strong relationships with regulatory agencies through effective written and verbal communication.
Support internal and external audits and contribute to regulatory intelligence and compliance initiatives.
Develop and maintain regulatory procedures and provide mentorship and training to colleagues and cross functional partners.
Maintain regulatory databases and support additional regulatory projects as assigned.