Senior Regulatory Affairs Specialist

Smith+Nephew; Mansfield (MA); On-site; USD 102,000 - 152,000; Full time

Benefits offered by this job

401k Matching

Tuition Reimbursement

Medical, Dental, Vision Coverage

Paid Holidays

Flexible Vacation Time

Parental Leave

Job summary

Smith+ Nephew is seeking a Senior Regulatory Affairs Specialist to shape regulatory strategies, secure global approvals, and ensure lifecycle compliance for medical devices. You will partner with cross‑functional teams to influence development and deliver patient‑centered healthcare solutions.

You will lead submissions, guide development and manufacturing, assess regulatory impact of changes, and mentor colleagues while building strong agency relationships.

Qualifications

• Bachelor's degree or equivalent in a scientific/technical field.
• 5+ years regulatory affairs experience in medical devices/healthcare.
• Strong knowledge of global regulatory requirements, medical products, and design controls.
• Experience managing regulatory submissions and working with agencies.
• Excellent analytical, writing, communication and project management skills.
• Ability to manage multiple priorities across diverse teams.
• RAPS Certification is a plus.

Responsibilities

• Develop and execute regulatory strategies for global registrations, clearances and approvals.
• Provide regulatory guidance to product development and manufacturing teams.
• Prepare, coordinate and manage regulatory submissions to global health authorities.
• Assess changes for regulatory impact and ongoing compliance.
• Build relationships with regulatory agencies through written and verbal communication.
• Support audits and contribute to regulatory intelligence and compliance initiatives.
• Develop and maintain regulatory procedures and mentor colleagues.
• Maintain regulatory databases and support additional regulatory projects.

Skills

Regulatory strategy

Regulatory submissions

Global regulatory knowledge

Project management

Technical writing

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree

Job description

Life Unlimited. At Smith+Neb 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**

What will you be doing?

• 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.

What will you need to be successful?

• 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.

We anticipate the application window for this opening to close on 09.17.2026

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.

Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by local and state policies.

You Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+ Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.