Senior Regulatory Affairs Specialist at Smith+Nephew in Mansfield, MA

Job description

• 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.

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.

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.
• RAPS Certification is a plus.

Skills

Required

• Knowledge of medical products
• Knowledge of design controls
• Excellent analytical skills
• Excellent problem solving skills
• Excellent technical writing skills
• Excellent communication skills
• Excellent project management skills

Preferred

• RAPS Certification

Benefits

• The anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate’s qualifications, job-related knowledge/skills, geographical location. You will be entitled to receive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.​