Senior Regulatory Affairs Specialist

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k

Tuition reimbursement

Medical leave

Wellness offerings

Fitness club discounts

Travel discounts

Job summary

Smith+Neb is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy, secure global product approvals, and ensure lifecycle compliance. You will collaborate with cross-functional teams to influence device development and bring healthcare innovations to patients worldwide.

The role requires 5+ years in regulatory affairs within medical devices, strong regulatory knowledge, and proven submission experience. Visa sponsorship is not offered.

Qualifications

• 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.

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.

Skills

Regulatory affairs

Global regulation

Medical devices

Project management

Technical writing

Education

Bachelor's degree in science or related field

Tools

Regulatory databases

Job description

Life Unlimited. At Smith+Neb 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.

• medical, dental, and vision coverage
• 401k
• tuition reimbursement
• medical leave programs
• a variety of wellness offerings

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/).

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

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

Smith+Neb 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.

We are a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Neb a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.