Senior Regulatory Affairs Specialist

smithnephew; Mansfield (MA); On-site; USD 102,000 - 152,000; Full time

Benefits offered by this job

401k Matching Program

Tuition Reimbursement

Discounts on fitness clubs

Discounted Stock Options

Paid Holidays

Job summary

Smith+ Nephew is seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and approvals across global markets. You will guide product development, coordinate submissions, and ensure lifecycle compliance.

The role requires 5+ years in regulatory affairs for medical devices, strong writing and communication, and experience with regulatory agencies. Visa sponsorship is not offered.

Qualifications

• Bachelor's degree or equivalent in a scientific/technical discipline.
• 5+ years of Regulatory Affairs experience in medical devices/healthcare.
• Strong knowledge of global regulatory requirements, medical products, and design controls.
• Experience managing regulatory submissions with regulatory agencies.
• Excellent analytical, writing, communication, and project management skills.

Responsibilities

• Develop and execute regulatory strategies to support global registrations, clearances and approvals.
• Provide regulatory guidance to product development and manufacturing teams.
• Prepare, coordinate, and manage regulatory submissions to global authorities.
• Assess regulatory impact of product and manufacturing changes.
• Maintain relationships with regulatory agencies through clear communication.

Skills

Regulatory strategy

Regulatory submissions

Regulatory guidance

Audits

Project management

Technical writing

Communication

Education

Bachelor's degree in science/engineering

Tools

Regulatory databases

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.

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.

Stay connected by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You . Unlimited . , life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer.