Senior Regulatory Affairs Specialist

Smith+Nephew•Mansfield, MA

5d•$101,500 - $152,250

About The Position

Smith+Nephew designs and manufactures technology intended to take the limits off living. The Senior Regulatory Affairs Specialist helps bring medical technologies to market and improve patient outcomes by developing regulatory strategies, securing global product approvals, and ensuring compliance throughout the product lifecycle. The position collaborates with cross-functional teams, influences product development, and supports healthcare solutions for patients worldwide. Visa sponsorship is not offered now or in the future.

Requirements

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

Nice To Haves

RAPS Certification.

Responsibilities

Develop and execute regulatory strategies for 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 relationships with regulatory agencies through 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.

Benefits

Medical, dental, and vision coverage.
401(k) and 401(k) matching programs.
Tuition reimbursement.
Medical leave programs and parental leave.
Wellness offerings and an Employee Assistance Program.
Health Savings Account with an employer contribution of $500+ annually.
Fertility and adoption assistance.
Flexible personal/vacation time off, paid holidays, flex holidays, and a paid community service day.
Mentorship and hands-on, team-customized training.
Discounts on fitness clubs, travel, and other offerings.
Discounted stock options.